Clinical Development
Accredited Consulting Service for Dr. Chachad Accredited Senior Consultant (ASC)
Executive Summary Video
The Appleton Greene Accredited Consultant Service (ACS) for Clinical Development is provided by Dr. Chachad and provides clients with four cost-effective and time-effective professional consultant solutions, enabling clients to engage professional support over a sustainable period of time, while being able to manage consultancy costs within a clearly defined monthly budget. All service contracts are for a fixed period of 12 months and are renewable annually by mutual agreement. Services can be upgraded at any time, subject to individual client requirements and consulting service availability. If you would like to place an order for the Appleton Greene Clinical Development service, please click on either the Bronze, Silver, Gold, or Platinum service boxes below in order to access the respective application forms. If you have any questions or would like further information about this service, please CLICK HERE. A detailed information guide for this service is provided below and you can access this guide by scrolling down and clicking on the tabs beneath the service order application forms.
Client Telephone Conference (CTC)
If you have any questions or if you would like to arrange a Client Telephone Conference (CTC) to discuss this particular Unique Consulting Service Proposition (UCSP) in more detail, please CLICK HERE.
Bronze Client Service
Monthly cost: USD $1,500.00
Time limit: 5 hours per month
Contract period: 12 months
SERVICE FEATURES
Bronze service includes:
01. Email support
02. Telephone support
03. Questions & answers
04. Professional advice
05. Communication management
To apply – CLICK HERE
Silver Client Service
Monthly cost: USD $3,000.00
Time limit: 10 hours per month
Contract period: 12 months
SERVICE FEATURES
Bronze service plus
01. Research analysis
02. Management analysis
03. Performance analysis
04. Business process analysis
05. Training analysis
To apply – CLICK HERE
Gold Client Service
Monthly cost: USD $4,500.00
Time limit: 15 hours per month
Contract period: 12 months
SERVICE FEATURES
Bronze/Silver service plus
01. Management interviews
02. Evaluation and assessment
03. Performance improvement
04. Business process improvement
05. Management training
To apply – CLICK HERE
Consultant Profile
Mr. Chachad is an approved Senior Consultant at Appleton Greene and he has experience in information globalization, management and marketing. He has achieved a Master of Science in Clinical Pharmacology, a Post-graduation Diploma in Pharmaceutical Marketing Management, a Bachelor of Medicine and a Bachelor of Surgery. He has industry experience within the following sectors: Pharmaceutical; Biotechnology; Healthcare; Consultancy and Education. He has had commercial experience within the following countries: United States of America; United Kingdom; Netherlands; India and China, or more specifically within the following cities: Newark NJ; London UK; Amsterdam NL; Mumbai IN and Beijing CN. His personal achievements include: developed new medicinal products; filed complex generics, biosimilars, vaccines; served as QPPV, led pharmacovigilance; expert signatory to clinical regulatory modules and facilitated clinical regulatory innovation. His service skills incorporate: clinical development; due diligence; medical affairs; medical writing and pharmacovigilance.
To request further information about Dr. Chachad through Appleton Greene, please CLICK HERE
Executive Summary
Clinical Development
Every pharmaceutical company or biotech company undergoes some or the challenges during development of medicinal products, whether these are new chemical entities, novel biologics, differentiated products, complex generics, biosimilars, vaccines, herbal products, medical devices or advanced therapies. Since the end-users are patients, it is of utmost importance to safeguard human well being and ethics, thereby ensuring that the medicine is safe and efficacious. In order to develop a quality product, that meets regulatory expectations, patient safety, patient compliance, effectiveness in the intended disease condition, company should be able to navigate formulation development challenges, manufacturing challenges, regulatory challenges and ensure successful clinical development. Rather the most time consuming element in the entire sequence of product development is clinical development. Robust designing of clinical development programme and quality execution with a favourable study outcome is the key to obtain successful marketing authorisation and launch of the medicinal product into the target market.
Service Methodology
The service is customised according to the needs of the pharmaceutical or biotech company who is seeking consultation to develop new medicinal product. The markets of interest for commercializing the new medicine are understood, and accordingly the medico-marketing landscaping is done. Thorough evaluation of the company developing new product is carried out with regards to parameters including, but not limited to the company’s existing product portfolio, presence in key therapeutic segments, geographical presence, competitive intelligence of marketed products and other products under development, R&D infrastructure, financial bandwidth, company’s risk appetite, regulatory requirements in chosen regions of development. Due diligence is conducted based on the company’s existing data on the proposed product followed by gap analysis to supplement the development programme. If the company has done preclinical studies including pharmacokinetics, pharmacodynamics, tissue distribution, safety pharmacology or in vitro studies, this data is reviewed for completeness and accuracy. Early clinical data if generated is also evaluated. If the human data is unavailable, the study programme is designed to prove the safety and efficacy of the investigational medicinal product in line with the regulatory requirements. Communications with the healthcare authorities in the form of pre-submission meetings, controlled correspondences, and written or face-to-face scientific advice meetings are facilitated if needed during the course of clinical development to increase the probability of successful clinical outcome and product approval. Necessary preclinical and clinical expertise is provided during such meetings or communications with the healthcare regulators in order to gain consensus on the best possible clinical development strategy for achieving successful registration of the product. Post registration support for the authorised medicine in form of pharmacovigilance obligations is also provided to the company, as needed.
Service Options
Companies can elect whether they just require Appleton Greene for advice and support with the Bronze Client Service, for research and performance analysis with the Silver Client Service, for facilitating departmental workshops with the Gold Client Service, or for complete process planning, development, implementation, management and review, with the Platinum Client Service. Ultimately, there is a service to suit every situation and every budget and clients can elect to either upgrade or downgrade from one service to another as and when required, providing complete flexibility in order to ensure that the right level of support is available over a sustainable period of time, enabling the organization to compensate for any prescriptive or emergent changes relating to: Customer Service; E-business; Finance; Globalization; Human Resources; Information Technology; Legal; Management; Marketing; or Production.
Service Mission
Service mission: Dr Chachad is a highly experienced pharmaceutical physician with over 20 years of global experience in the areas of medical affairs, medical marketing, clinical regulatory affairs, medical writing, drug safety in clinical trials and post authorization era, preclinical development and clinical development of new medicinal products including innovative drugs, complex generics, branded generics, biologics and biosimilars, medical devices, herbals, nutraceuticals & cosmetics, advanced therapies and even vaccines. He is a strategic leader in translational research, medical affairs and drug safety with expert knowledge of legal and regulatory requirements across these areas of expertise. He is a strong proponent of clinico-regulatory innovation, digital transformation and patient centricity in the development of new medicines. His understanding of global clinical requirements has yielded successful product registrations in most regulated markets across the globe including developed markets such as EU and US, as well as emerging markets such as India, Russia, China and Brazil. He is an acclaimed speaker at various international seminars and conferences on clinical research and pharmacovigilance, and an expert faculty in the functional areas of drug development and patient safety at the teaching and training institutes in Asia and Europe. He has published extensively in the peer-reviewed journals and has authored a book chapter on clinical development in reputed Burger’s Medicinal Chemistry, Drug Discovery and Development. As an expert consultant, he provides a strategic drug development solution to pharmaceutical and biotechnology companies thereby accelerating regulatory filing, approval and market launch of new medicinal products, and enabling patients to gain early access to affordable, quality, safe and effective medicines for better and healthier life.
Service Objectives
The following list represents the Key Service Objectives (KSO) for the Appleton Greene Clinical Development service.
- Global Development
Product development is a complex journey, not only driven by science, but also by varying regulatory requirements in different geographies. Although ICH (International Council for Harmonisation) exists for more than four decades to standardize the technical requirements for pharmaceuticals for human use, there still lies many differences between the specific product development requirements, may it be a new drug product, biologic or a generic. In case of a new chemical entity, the process starts with identification of target in the pathophysiology of the disease condition. Then the chemical or biological compounds are screened against these targets in preclinical studies and bioassays resulting in identification of the lead candidate that is taken for further development. Preclinical studies on the lead compounds include toxicity studies, pharmacokinetic studies, pharmacodynamics studies, tissue distribution studies. Lead compounds are optimized by making changes to improve their pharmacokinetic and / or pharmacodynamic (PD) profile or reduce toxicity. The extent of preclinical studies also depends on the market of interest for the new product registration. Optimized candidate becomes a potential product ready for human clinical trials, which are then carried out in different phases: phase I, phase II, phase III and phase IV. Both strategic and operational support will be provided to the company for their complex clinical developments ensuring that the new medicines get expedited regulatory approvals in developed markets (such as EU, US, UK) and in emerging markets (such as India, Russia, China & Brazil). So, the crux here is to design and conduct appropriate preclinical and clinical program for a medicinal product, based on which the company can achieve successful marketing authorization worldwide. - Clinicoregulatory Innovation
Clinical development of a new medicinal product is driven by formulation development challenges, regulatory challenges, and increasing focus on the patient centricity and digital innovation. It is important that the new drug product or medicinal product undergoes appropriate clinical evaluation to ensure that ultimately quality medicine with proven safety and efficacy is delivered to the end user i.e. patient who consumes it for health benefit. Taking into consideration the factors such as the region specific regulatory requirements, clinical operations feasibility, research cost & time optimization, the companies will be provided with the best clinico-regulatory approach for early registration and commercialization of the drug products in global markets. In case of new chemical entities, new therapeutic entities (line extensions and label expansions), novel biologics, preclinical and clinical development is a very costly and time-consuming process. On an average, bringing a molecule from its first human trial to marketing application takes 10 years; and the average cost has nearly tripled over the past two decades to be higher than US$2 billion. It is also a high-risk business. The phase-to-phase transition rates are 64% (I–II), 32% (II–III), 60% (III to marketing application) and 83% (regulatory approval), resulting in a low overall success rate of 10%. The innovation in clinical regulatory approach will maximize the probability of successful clinical outcome in the studies and new product registrations will be achieved with cost and time excellence so that the prescribing doctors and treated patients get the benefit of newer and better medicines faster. - Patient Safety
Safety evaluation is a central component in all stages of the drug development lifecycle. Regulatory agencies around the world and the pharmaceutical industry are taking a more comprehensive and holistic approach to safety evaluation in drug development. Prior to the marketing authorization of a drug, rigorous safety monitoring and evaluations from preclinical to all stages of clinical trials are required. Pharmaceutical sponsors need to adequately characterize the safety profile of the product in order to obtain regulatory approval and marketing authorization. The approved product label contains the essential information about the product’s benefits and risks. In case of clinical trials, if there are unexpected serious adverse reactions to the investigational medicinal product, the companies are obliged to report these to the regulatory bodies of those regions where these trials are carried out and intended for submission. Pharmacovigilance in the post-authorisation era or continued vigilance in safety is also critical as more data and experience is gathered from a broader patient population once the product is on the market. Healthcare regulators across the globe have defined guidance documents and regulations in place to ensure good pharmacovigilance practices. These include appointment of a qualified person for overseeing and maintaining the company’s pharmacovigilance systems, creation of pharmacovigilance system master file to provide an overview of company’s authorised medicines, timely reporting of adverse events to the regulators, risk management planning, signal management activities, and regular trainings and audits to ensure research compliance and marketing of only those products who have positive risk benefit ratio. - Medical Writing
It is extremely crucial that the documentation is prepared appropriately for the clinical development, regulatory submission and for pharmacovigilance purposes. The purpose of this service objective is to help clients by preparing clear and comprehensive non-clinical and clinical overviews for regulatory dossier (modules 2.4, 2.5, 2.6 and 2.7), Addendum to Clinical Overview as part of renewals, Paediatric Investigation/Study Plan, Orphan drug designation dossier, target product profile creation (TPP) in case of new drug products, clinical development plan, clinical study documents (including study protocol, investigators brochure, clinical study report), clinical and nonclinical parts of the investigational medicinal product dossier (IMPD), manuscripts for publications, regulatory communications including briefing books for scientific advice meetings, and pharmacovigilance documents such as standard operating procedures, safety data exchange agreements, pharmacovigilance system master file, aggregate reports and risk management plans. Once the marketing authorisations are granted to the pharmaceutical and biotech companies for their new medicinal products, promotional activities begin to garner sales from their new medicine launches into respective territories. However, the promotion of medicinal products is governed by local advertising laws and regulations to ensure that the safe and effective medicines ultimately reach the patients. So the companies have to ensure that the medical marketing materials such as patient information leaflets, labeling information, flyers, digital advertisements, social media posts, health journal articles are written in such a manner that these are not misleading and only safe and effective medicines are promoted for the benefit of public health. With effective medical writing across stages of product development life cycle, the company is committed to highest quality standards for the developed new medicines. - Due Diligence
Given the increasing complexities of new medicinal product development, stringent regulatory requirements from most healthcare authorities and increasing clinical development costs, day by day it is becoming more and more challenging for pharmaceutical and biotechnology companies to invest into new medicinal product developments. These technical and commercial complexities apply not only to the development of new chemical entities but also when the companies are developing novel therapeutic entities (including novel drug delivery platform technologies, drug repurposing) and even complex generics such as liposomal formulations, depot injections, peptides, inhaled drug device combinations and topical products. Business alliances and co-developments are hence becoming increasingly popular in these aforementioned areas. Therefore, before investing money, resources and efforts into research and development, it is very important to do thorough due diligence and gap analysis of licensing opportunities. This will include detailed review and evaluation of the existing data on the quality, production and control of the medicinal product being developed as well as the data generated so far from nonclinical and clinical studies to demonstrate the safety and efficacy of the new medicinal product With the right in-licensing opportunity chosen, the companies can maximize the probability of successful product development and market launch. Further one of the key challenges in global clinical development of complex products is the diversity in nonclinical and clinical requirements for the same product from different healthcare regulators. At times, there are uncertainties despite regulatory guidance documents. In such cases, it is essential that you identify right clinical research partner who helps you to navigate this situation, design strategic development plan and even represent you at the scientific advice meetings with the regulators, may it be a pre-IND/pre-NDA/pre-BLA meeting with the FDA or pre-submission meeting with any of the National Competent Authorities in the Europe.
Testimonials
Catawba Research
“Under high pressure to swiftly respond to the FDA’s inquiry, the ability to deliver a comprehensive and thoroughly researched document in just two days was a key component of our successful response to the inquiry. Commitment to excellence, rapid delivery, and profound understanding of the subject matter played a pivotal role in the overall success of our response. Without a doubt, Dr. Chachad’s exceptional performance significantly contributed to our ability to meet the tight deadline and present a well-crafted response to the FDA’s question. His dedication and expertise make him an invaluable asset, and I wholeheartedly recommend him for any future projects that demand excellence, precision, and an unwavering commitment to success.”
Koru Science
“The company has initiated the development of a new combination product and wanted to explore the way forward for its clinical development in pursuance of registration in key markets such as US and Europe. The objective was to understand the most optimal preclinical and clinical development programme that will be acceptable to both the key regulators and that can be executed successfully within reasonable timeframe and at an optimal cost. A thorough due diligence on the in vitro studies was done including published literature surveillance in order to substantiate the available study data. The pre-IND document for the meeting was fine tuned with a robust clinical programme to meet most regulatory expectations (yet with an optimal package including a waiver request for the most routine preclinical/clinical studies).”
Lupin Limited
“I have worked closely with Dr Chachad while I was responsible for regulatory submission to Europe and Australia. During this period, he had almost single-handedly offered support to Regulatory submissions in Europe and Australia with respect to clinical modules. He used to understand regulatory guidelines in a holistic manner besides paying attention to details and differences in requirements of different Health authorities. This helped us to tackle query responses in timely manner. Due to his scientific acumen and can-do attitude, Dr Chachad was always a dependable partner in the clinical and nonclinical medical writing work where submission tasks are highly time bound.”
Cipla Limited
“I worked closely with Dr Chachad to help prepare for an inspection with focus on pharmacovigilance. Excellent understanding of global clinical, safety and regulatory requirements and successful changes made to the organization’s pharmacovigilance system with regards to the standard operating procedures, timely safety reporting and adequate documentation of safety communications and safety literature resulted in no safety observations during the regulatory inspection. ”
Dr Reddy’s
“Dr Chachad has driven innovative clinical strategies with cost and time excellence in the execution of clinical trials enabling several product registrations (including complex generics and differentiated products) and high quality clinical and pre-clinical data complying ethical standards and regulatory requirements. He led clinical and medical excellence in the vaccine development programme during global pandemic. He was also instrumental in helping the organization establish its medical cannabis franchise and understand its way forward for pharmaceutical registration in more stringent regulatory markets. He also drove digital transformation within clinical organisation in the areas of preclinical development, clinical development, biopharmaceutics and biological characterisations.”
More detailed achievements, references and testimonials are confidentially available to clients upon request.
Industries
This service is primarily available to the following industry sectors:
Pharmaceutical
The pharmaceutical industry is the industry involved in the discovery, development, production and marketing of drug products, food supplements, herbal products, veterinary products. Such products are meant to be used as medicines by the patients for the treatment or prevention of the disease conditions. Either the medicines are developed as new drug products, wherein the active pharmaceutical ingredient is a new substance; or these are developed as generic products, wherein the active substance in the drug composition is previously known and identical to the marketed product from the innovator company. Pfizer, Johnson & Johnson, Novartis, Astra Zeneca, Merck & Co Inc., Roche, GSK, AbbVie, Eli Lilly are some of the leading multinational pharmaceutical companies developing innovative medicinal products. The innovator companies face fierce competition on pricing from generic companies after the patent expiry of drug products. Some of the leading generic market players include Teva, Sandoz, Cipla, Lupin, Mylan and Dr. Reddy’s. The industry continues to grow and the total market was valued at around 1.5 trillion USD in 2022. This industry sector has shown significant growth despite recent global pandemic because of new medicines being continuously researched and developed worldwide.
Biotechnology
While the pharmaceutical companies develop chemically synthesized medicinal products, the biotechnology companies develop medicines from living organisms. The applications of biotechnology include discovery and development of novel biological products, biosimilars, vaccines, diagnostics and even advanced therapies (which utilise cell therapy, gene therapy and tissue engineering). For instance, there are several breakthrough treatments based on biotechnology platform in therapeutic indications such as endocrine disorders, autoimmune diseases, cancers and neurodegenerative conditions. While traditionally the biotechnology was used to produce the alternatives to endogenous molecules in larger yields than the conventional sources, now the biotechnology researchers have gone further deep to understand the pathophysiology of the disease at the cellular or gene level for the development of therapeutic proteins including monoclonal antibodies. Moderna, Novo Nordisk, BioNTech, Vertex, Regeneron and Incyte are some of the leading biotech companies developing medicinal products. Biotechnology industry also has other applications such as refining of industrial processes through enzymes that catalyse chemical reactions, and are used in the production of detergents, pulp and paper, textiles, and biomass. The industry also has its applications in agriculture such as improved animal feed and in the production of vaccines for the livestock. The global biotechnology market was estimated at 1.3 trillion in 2022 and is expected to grow at a CAGR of 14% from 2023 to 2020.
Healthcare
Integrated into the healthcare is research and development of newer medicines, prevention and treatment of patients, rehabilitation of certain medical conditions and palliative care in terminal illnesses such as cancers. The healthcare or hospital industry has three key components: medical services, medicinal products and healthcare costs. The key stakeholders include hospitals, clinics, doctors, patients, care givers or nurses, laboratories, pharmaceutical and biotech companies, research organisations, pharmacies, medical device manufacturers, healthcare authorities, and insurance companies. Since the healthcare sector deals with human wellbeing and safety, it is very important that the organisations involved in providing healthcare are not only equipped with good infrastructure and qualified and trained human resources but also with a good governance and good financial management to ensure that good care is provided to the patients. Safety and ethics are of utmost importance when it comes to provision of quality care to the patients. Like every other industry, healthcare industry is also undergoing significant digital transformation. This includes use of innovative digital solutions to improve the delivery of healthcare for the benefit of public health. While on one side, the digital analytics is used in the research and development of new medicines, prediction of outcomes in clinical trials through artificial intelligence and machine learning; on the other side, electronic health record systems and e-health technologies are being widely used in the hospitals in current times for ensuring robust healthcare infrastructure at the hospitals. Further there are digital diagnostic tools which help healthcare providers diagnose medical conditions more accurately; and there are digital therapeutic solutions which allow more personalized, expedited and patient-centric approach towards clinical decision making based on big data and provision of holistic healthcare management.
Consultancy
This industry thrives on the provision of independent expert advice to the third party on the matters of concern, challenges or in cases where specialized expertise is needed in the absence of trained or sufficiently experienced in-house staff within the organisations. The consulting firm provides this professional service to the client at an honorarium which could be based on hourly basis, daily basis or monthly or long term retention contractual basis. The consultancy may be run just by one expert or it could be a group of several experts with different qualifications, levels of experience and areas of expertise. The core areas of consultancy include research and development, corporate strategy, technical operations, management, organisational structure, company finance and information technology. The consulting could range from or begin with mere provision of the requested information to the client who is not cognizant of the same; to a deeper investigation or thorough diligence of the consulting area and arrival at the recommended action plan to resolve the matter or ensure the effectiveness of business solution to promote company growth in the desired space. The size of global consulting market is estimated to be up to 300 billion USD and the consulting industry is presently dominated by the developed markets such as Europe and United States rather than the emerging markets like Middle East, LATAM and Africa. Some of the leading market players include McKinsey, Deloitte, KPMG, PWC and Boston Consulting Group, Ernst and Young, Accenture. Mergers and Acquisitions have become more prominent even in this industry sector since last 15 years with an objective to expand the existing operations, explore new skills or industries or widen the geographical presence of the consulting firm.
Education
The education industry is one of the largest growing industries and its global market is expected to reach $8 trillion in value by 2030 from $6 trillion in 2022. This sector also generates large scale revenues and employment. In the United States, it generated over 400 billion dollars from higher education alone. Globally, the governments are expected to develop and implement strategies to promote higher education, which will in turn translate into better skilled labour, and this can ultimately have a positive impact on the country’s GDP. The fast growth of this industry sector is fostered by the use of digital technology since it allows faster and wider spread of information compared to traditional ways of classroom learning. Digital education or E-learning, through its novel methodologies, significantly improves the quality of learning, making the educational system not only more accessible and efficient but also less expensive as against the conventional methods. The key stakeholders of education industry include students, teachers, schools, colleges, universities, administrators, lecturers, professors, librarians and counsellors. With the growth of technological capabilities in teaching and learning, such as artificial intelligence, Big Data, mobile learning, and Virtual Reality, the gamified learning has also established its own identity as means of more enjoyable learning mechanism. In late 2022, the search engine such as ChatGPT further revolutionized this industry through provision of its conversational application approach for personalised learning. Also, as a part of the education system, the companies across industries seek expert professionals with leadership experience to impart knowledge and training within workplace, nurture soft skills, encourage critical thinking and problem solving, that are ultimately aimed at enhancing the productivity of the organisation and maximizing the overall business value of the company.
Locations
This service is primarily available within the following locations:
New Jersey
The largest industries driving New Jersey’s economy include pharmaceuticals and life sciences, financial services, manufacturing, technology, and transportation and logistics. The healthcare and life sciences industry continues to grow due to the concentration of medical institutions and demand driven by an elderly population. In fact, New Jersey reportedly has the highest concentration worldwide of highly qualified, trained and experienced scientists and engineers in the world. The healthcare sector employed an average of 76,510 or 2.4% of all private sector workers in the state for 2020. Those numbers comprised about 1.3% on a national scale. Over a five-year period from 2015 to 2020, New Jersey’s pharmaceutical industry increased by 19.9%. Teaching hospitals, research institutes, and clinical trial organisations are all lucrative for these biopharmaceutical companies to invest into research and development of new medicinal products. New Jersey is also an attractive base for financial services firms due to population density and proximity to New York City. Finance industry firms represent industries including banking, investing, such as securities and commodities, insurance, and accounting. With more than 218,000 employees in 2020, the financial services industry accounted for 6.8% of total private sector jobs in New Jersey and contributed $32 billion to the state economy; 6.6% of the state’s GDP in 2020. accounted for approximately $54 billion of state gross domestic product (GDP) in 2019, about 10.1% of all output. New Jersey also shows a very high concentration of information technology employees in the nation with more than 5,000 information and technology companies based here.
London
London’s business economy stands as a testament to the city’s resilience and adaptability in the face of global challenges. London is a major economic powerhouse, and its GDP contributes significantly to the overall GDP of the United Kingdom. As one of the world’s leading financial and commercial hubs, London continues to experience a robust and growing business economy, showcasing a dynamic blend of traditional sectors and emerging industries. The financial district, often referred to as the City of London, remains a powerhouse in global finance. Renowned for its historic institutions such as the Bank of England and Lloyd’s of London, the city attracts financial institutions, investors, and businesses from around the globe. The presence of multinational corporations and a thriving ecosystem of fintech startups contribute to the city’s reputation as a fintech hub, leading the way in technological innovation within the financial sector. Beyond finance, London’s business landscape has diversified significantly in recent years. The tech sector has experienced a boom, with the East London Tech City, also known as Silicon Roundabout, becoming a focal point for technology and digital innovation. Startups and tech giants alike are drawn to the city’s vibrant atmosphere, access to talent, and supportive infrastructure. The creative industries, including media, fashion, and design, also play a pivotal role in London’s economic growth. The city’s creative scene fosters innovation and attracts a global audience. London Fashion Week, for instance, serves as a platform for emerging designers and establishes the city as a trendsetter in the fashion world. Moreover, the green economy is gaining traction in London, reflecting a commitment to sustainability and environmental responsibility. Initiatives promoting renewable energy, green infrastructure, and sustainable practices are becoming integral components of the city’s economic strategy. London’s connectivity, both physical and digital, further enhances its economic prowess. The city’s international airports, extensive public transportation network, and digital infrastructure make it also a preferred destination for businesses seeking global reach.
Amsterdam
Amsterdam’s business landscape is significantly influenced by its vibrant tourism sector, which plays a crucial role in the city’s economic vitality. The Dutch capital, renowned for its picturesque canals, historic architecture, cultural attractions, and liberal atmosphere, attracts millions of visitors each year. The tourism sector in Amsterdam encompasses various industries and businesses that cater to the diverse needs and preferences of travellers. While the tourism sector is a significant contributor to Amsterdam’s economy, the city is also working towards achieving a balance to ensure the sustainable development of this industry, considering the impact on local residents and the environment. Amsterdam has emerged as a thriving tech and innovation hub, attracting startups, tech giants, and entrepreneurs alike. The city’s strategic location, combined with a highly educated workforce and a supportive ecosystem, has fostered the growth of innovative enterprises. Areas like the Amsterdam Science Park and the A Lab incubator have become focal points for cutting-edge research and development. Amsterdam’s life sciences sector is experiencing substantial growth, positioning the city as a hub for innovation, research, and development in the field of biotechnology, pharmaceuticals, and health sciences. Amsterdam boasts world-class research institutions and universities that are actively engaged in life sciences research. The University of Amsterdam and VU University Medical Center are among the institutions driving cutting-edge research in areas such as genomics, personalized medicine, and neurobiology. The convergence of life sciences with technology is evident in Amsterdam’s growing health technology and digital health sector. Companies in this space focus on developing innovative solutions, such as digital therapeutics, telemedicine, and health analytics. Amsterdam’s thriving startup ecosystem is particularly conducive to the growth of these technology-driven health initiatives. The contribution of this city to Dutch economy certainly makes it very competitive as against the other European member states for the foreign businesses to invest and flourish. In 2022, the GDP in the Netherlands was 54,700 euros and the province with the highest GDP per capita was North Holland, which included the capital city of Amsterdam, at 70,400 thousand euros.
Mumbai
Mumbai, often dubbed the financial capital of India, stands as a formidable business powerhouse, contributing significantly to the country’s economic landscape. During the financial year 2023, the real gross domestic district product of the Indian megacity of Mumbai was 3.93 trillion Indian rupees. The city’s GDP reflects its economic might, with a diverse array of industries driving growth. At the core of Mumbai’s economic strength lies its status as a financial hub. The Bombay Stock Exchange (BSE), located in the city, is one of the oldest and most influential stock exchanges in Asia. Mumbai is also home to the Reserve Bank of India (RBI), further solidifying its role in shaping the nation’s monetary policies. The city’s GDP is bolstered by a robust industrial base that spans sectors such as finance, information technology, healthcare, media, textiles, and diamond polishing. The presence of numerous corporate headquarters, both Indian and multinational, underscores Mumbai’s significance as a business destination. The city’s ability to attract and nurture entrepreneurship is reflected in its thriving startup ecosystem, contributing to innovation and job creation. Mumbai’s strategic location as a major port facilitates extensive trade and commerce. The port serves as a vital gateway for imports and exports, connecting the city to global markets and contributing to its economic vibrancy. The real estate sector, while presenting challenges such as high property prices, plays a crucial role in Mumbai’s GDP. The iconic skyline dotted with commercial and residential developments is emblematic of the city’s economic prowess. Furthermore, Mumbai’s influence extends to the cultural and entertainment spheres, with Bollywood, the Hindi film industry, headquartered in the city. This industry not only adds to the GDP but also contributes significantly to the city’s cultural identity. Mumbai’s GDP reflects its enduring status as a dynamic and influential business powerhouse on both the national and global stages.
Beijing
Beijing, the capital of China, boasts an incredibly attractive economy that serves as a powerhouse for the nation’s overall economic growth. Beijing’s GDP has consistently ranked among the highest in the world, reflecting the city’s robust economic activities and dynamic business environment. One of the key drivers of Beijing’s economic success is its diverse and thriving industry sectors. The city has evolved from being primarily known as a political and cultural centre to a global economic hub. . Beijing’s strategic location, serving as a gateway to the vast Chinese market, further enhances its appeal for businesses looking to establish a strong presence in China. The finance and technology sectors play a significant role in shaping Beijing’s economic landscape, with the city serving as a home to numerous multinational corporations and cutting-edge technology firms. The rise of companies in areas like artificial intelligence, e-commerce, and fintech has contributed substantially to the city’s economic vibrancy. Moreover, Beijing’s industrial sectors span a wide range, including manufacturing, information technology, telecommunications, and biotechnology. The city’s strategic focus on innovation and research and development has fostered the growth of high-tech industries, making it a leader in technological advancements. The Zhongguancun Science Park, often referred to as China’s Silicon Valley, is a testament to Beijing’s commitment to fostering innovation and entrepreneurship. In recent years, Beijing has also been at the forefront of sustainable development initiatives, promoting green industries and environmentally friendly practices. The city’s commitment to transitioning towards a more sustainable and eco-friendly economy aligns with global efforts to address climate change and environmental concerns. The influx of domestic and international investments, coupled with a well-educated and skilled workforce, contributes to the city’s economic attractiveness and shaping its global identity beyond being solely a political and cultural capital.
Clients
This service’s current clients or employers include:
Roche
Throughout our 125-year history, Roche has grown into one of the world’s largest biotech companies, as well as a leading provider of in-vitro diagnostics and a global supplier of transformative innovative solutions across major disease areas. Our commitment to our people, partners, stakeholders and, most importantly, our patients remains as strong as it was on the first day of our journey. For over 125 years, we’ve been developing diagnostics and medicines for a wide range of chronic and life threatening health conditions that continue to revolutionise healthcare. Being a family-owned company allows us to focus on long-lasting investments, take greater risks and explore innovative new ways to improve people’s health around the world.
As a global leader in healthcare, we are one of the world’s largest biotech companies and the leading supplier of in-vitro diagnostics. We’re an innovator across major disease areas, including oncology, neurology, infectious diseases, and ophthalmology. We’ve partnered with many forward-thinking, entrepreneurial and ground-breaking organisations that have one thing in common – the belief that cutting-edge science and technology can and will improve human health.
We focus on fitting treatments to patients: providing the right therapy for the right patient to ensure the best response at the right time for the right value. Our approach combines our rich expertise in pharmaceuticals and diagnostics with expanded data science capabilities to drive more effective and efficient research and enable better therapeutic decisions for patients.
Working in partnership with third parties, we are better positioned to offer integrated solutions that improve medical and health outcomes. We work with stakeholders across the healthcare ecosystem to broaden access to our solutions for people who need them.
Additionally, we are passionate about advancing science, regardless of where it comes from, by identifying the best innovations, whether internal or external, and delivering them to patients.
www.roche.com
Lupin Pharmaceuticals
Lupin’s journey is a testament to the potential of human imagination, compassion, and the unwavering pursuit of a better tomorrow. Established in 1968 by our visionary founder, Dr. Desh Bandhu Gupta, Lupin has evolved from humble beginnings to become a global healthcare leader. Headquartered in Mumbai, India, we have expanded our footprint across the U.S., LATAM, APAC and EMEA regions, operating in over 100 countries and offering adverse portfolio of over 1,000 products.
Inspired by the resilient lupin flower that nourishes the soil while thriving in challenging conditions, Lupin remains committed to its mission of making quality healthcare accessible to all. We recognize the importance of nurturing the communities we serve and leaving a positive impact on society.
With our robust manufacturing capabilities and strong research and development, we have emerged amongst the leaders in generics, complex generics, APIs, specialty, and biologics. Lupin’s commitment to innovation and patient-centricity has fuelled its success in therapeutic areas such as cardiovascular health, tuberculosis, diabetes, respiratory, gastrointestinal disorders, and women’s health.
At Lupin, we understand that true success lies in the convergence of business growth and social impact. Beyond healthcare, we are dedicated to the upliftment of the communities we serve. This commitment is channelled through the Lupin Human Welfare and Research Foundation (LHWRF), which focuses on two pillars: Improving Lives and Improving Livelihood. Across 5,431 villages in nine states of India, we positively impact the lives of over 2.5 Mn people, reflecting our commitment to social responsibility and sustainable change.
Our journey is guided by the belief that healthcare should be accessible, affordable, and of the highest quality. We strive to advance our infrastructure, embrace innovation, and expand our presence in high-growth markets to better serve the evolving needs of patients worldwide.
As we embark on the next chapter of our story, were main committed to our vision, mission, and core values. With boundless optimism, we embrace the challenges that lie ahead, confident that our collective efforts will continue to make a lasting impact on the world of healthcare.
www.lupin.com
Cipla
Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of Caring for Life and deep-rooted community links wherever it is present, make it a partner of choice for global health bodies and stakeholders.
www.cipla.com
Dr. Reddy’s
We started in 1984 with a modest investment and a bold vision. Today, with research and development centres, manufacturing facilities and commercial presence across the globe, we serve over half a billion patients worldwide.
We are committed to providing access to affordable and innovative medicines, driven by our purpose of ‘Good Health Can’t Wait’.
Our products and services are spread across our core businesses of Active Pharmaceutical Ingredients (API), generics, branded generics, biosimilars and over-the-counter pharmaceutical products around the world. We work towards meeting unmet patients needs in the areas of gastro-enterology, cardiovascular, diabetology, oncology, pain management and dermatology. We are investing in businesses of the future including drug discovery, clinically-differentiated assets and digital healthcare.
www.drreddys.com
Catawba Research
Catawba Research is named for the Catawba River, which starts in the Appalachian Mountains and drains into the Piedmont region of North Carolina. As a life sciences company and water being a life source, the name is quite fitting for a CRO seeking to increase the quality of life for people suffering from treatable diseases.
Catawba Research is a trusted research organization defined by its nimble approach to study design and execution. Boasting over 100 years of C-suite experience and an expansive and evolving portfolio of therapeutic success, we help set the standard for CRO leadership. With consistent scientific engagement and targeted fiscal responsibility, we set ourselves apart from the competition. We believe quality is found in the details, and our precision focus on timelines and cost-conscious design allows us to deliver the right results at the right time — for the right price. In fact, while only 20% of clinical trials finish on time, 70% of all clinical trials partnered with Catawba Research either meet or exceed their timeline objectives.
Catawba utilizes dedicated international management teams and executive-level oversight to guarantee protocol compliance and keep every component of a project on track. What’s more, our “Always Audit Ready” TMF documentation guarantees you are prepared to confidently overcome any regulatory obstacle and push your project forward without delay. This proactive approach has awarded us over 30 regulatory approvals — the most achieved without a single change order. On top of that, our therapeutic portfolio is growing rapidly, as we leverage our impressive track record in dermatology and women’s health into more recent triumphs in pulmonary, autoimmune and neurology research.
Despite this growing success as a global CRO, Catawba retains an agile approach to study delivery and assigns active roles to its executives. With a fixed-budget mentality, innovative trial management and robust quality assurance, Catawba is a full-service CRO with a passion for people — those patients in need of treatment and those professionals looking to unlock new possibilities in health care.
Remembering the patient is always the reason we do our work, Catawba Research seeks to be a life force in the field of clinical research building confidence in our partners throughout the execution of a clinical trial. We do this by committing to excellence, collaboration and transparency.
www.catawbaresearch.com
Service Benefits
Globalization
- Business growth
- Global positioning
- Company image
- Brand value
- Healthcare innovation
- Patient centricity
- Strategic alliances
- Delivering productivity
- Regulatory Approvals
- Competitive advantage
Management
- Global strategy
- Operational excellence
- Research compliance
- Integrated development
- Company reputation
- Brand value
- Worldwide presence
- Quality medicines
- Delivering productivity
- Process improvement
Marketing
- Safe medicines
- Effective medicines
- Prescription loyalty
- Patient adherence
- Company reputation
- Brand value
- Repeat business
- Sustainable growth
- Legal compliance
- Competitive positioning
Bronze Service
Monthly cost: USD $1,500.00
Time limit: 5 hours per month
Contract period: 12 months
Bronze service includes:
01. Email support
02. Telephone support
03. Questions & answers
04. Professional advice
05. Communication management
SERVICE DESCRIPTION
The Bronze Client Service (BCS) for Clinical Development provides clients with an entry level option and enables client contacts to become personally acquainted with Dr. Chachad over a sustainable period of time. We suggest that clients allocate up to a maximum of 5 Key Employees for this service. Your Key Employees can then contact the consultant via email, whenever they feel that they need specific advice or support in relation to the consultant’s specialist subject. The consultant will also be proactive about opening and maintaining communications with your Key Employees. Your Key Employees can list and number any questions that they would like to ask and they will then receive specific answers to each and every query that they may have. Your Key Employees can then retain these communications on file for future reference. General support inquiries will usually receive replies within 48 hours, but please allow a period of up to 10 business days during busy periods. The Bronze Client Service (BCS) enables your Key Employees to get to know their designated Appleton Greene consultant and to benefit from the consultant’s specialist skills, knowledge and experience.
Silver Service
Monthly cost: USD $3,000.00
Time limit: 10 hours per month
Contract period: 12 months
Bronze service plus
01. Research analysis
02. Management analysis
03. Performance analysis
04. Business process analysis
05. Training analysis
SERVICE DESCRIPTION
The Silver Client Service (SCS) for Clinical Development provides more time for research and development. If you require Dr. Chachad to undertake research on your behalf, or on behalf of your Key Employees, then this would understandably require more time and the Silver Client Service (SCS) accommodates this. For example, you may want your consultant to undertake some research into your management, performance, business, or training processes, with a view towards providing an independent analysis and recommendations for improvement. If any research and development, or business analysis is required, then the Silver Client Service (SCS) is for you.
Gold Service
Monthly cost: USD $4,500.00
Time limit: 15 hours per month
Contract period: 12 months
Bronze/Silver service plus
01. Management interviews
02. Evaluation and assessment
03. Performance improvement
04. Business process improvement
05. Management training
SERVICE DESCRIPTION
The Gold Client Service (GCS) for Clinical Development is intended for more detailed evaluation and assessment, that may require your Key Employees to have monthly meetings or interviews with Dr. Chachad. These meetings and interviews can be conducted over the telephone, Skype, or by video conference if required. The consultant can also attend your business premises, an Appleton Greene office, or another mutually beneficial location, but please note that clients are responsible for the costs of any disbursements separately, including travel and accommodation. This service enables you to integrate the specific skills, knowledge and experience of your designated consultant into your Key Employee management team. The Gold Client Service (GCS) can also incorporate training workshops, business presentations and external meetings with customers, suppliers, associations, or any other business-related stakeholders.
Platinum Service
Monthly cost: USD $6,000.00
Time limit: 20 hours per month
Contract period: 12 months
Bronze/Silver/Gold service plus
01. Project planning
02. Project development
03. Project implementation
04. Project management
05. Project review
SERVICE DESCRIPTION
The Platinum Client Service (PCS) for Clinical Development is our flagship service and will be required if you need Dr. Chachad to facilitate the planning, development, implementation, management, or review of a particular project relating to his specialist subject, which would obviously require more time and dedication. This service enables you to reserve up to 12.5% of the consultant’s working month and provides a more hands-on service as and when required. If you need more time than this, then this can always be arranged, subject of course to the consultant’s ongoing availability. The benefit of having an external consultant involved in projects is they provide an independent perspective and are not influenced by internal politics, day-to-day responsibilities, or personal career interest. They provide objectivity, specific knowledge, skills and experience and will be entirely focused upon the tasks at hand. The Platinum Client Service (PCS) will provide your organization with a valuable resource as and when you need it.