MISSION
To provide a strategic drug development solution to pharma and biotech thereby accelerating regulatory filing, approval and market launch
Why us?
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As the expert consultants, we offer a diverse portfolio of services covering all stages of the product life cycle: predevelopment (product portfolio selection), preclinical phase, clinical phase, dossier review and post-authorisation.
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We bring in a breadth of clinical development strategy and execution expertise across medicinal product categories, dosage forms, therapeutic segments for regulatory submissions worldwide.
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We offer comprehensive medical writing services and end-to-end pharmacovigilance solutions (including establishment of in-house PV division & quality systems, and acting as the EU QPPV) at a competitive pricing.
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Based on our deep regulatory understanding and rich experience working closely with the global healthcare authorities, we expedite your product development and regulatory filing.
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We leverage innovative clinico-regulatory solutions to maximize the probability of successful first cycle regulatory approvals.
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We are the leading experts with global drug development and regulatory submission experience covering developed markets such as North America, Europe, Canada, Australia as well as the emerging markets such as India, China, Brazil and Russia.
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You are always the high priority for us. We work with you as an extended arm of your organization striving together for successful drug product registration and early launch into the market.
Dr Siddharth Chachad
Founder and Director - Reguclin Consulting
Siddharth Chachad is a pharmaceutical physician with over 20 years of experience in the areas of medical affairs, drug safety and global 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 India, Czechia and Netherlands. He has published extensively in the peer-reviewed journals and has written a book chapter on clinical development in reputed Burger's Medicinal Chemistry, Drug Discovery and Development.