Dr. Sanjeev K. Gupta
Dr. Sanjeev K. Gupta, Founder and CEO of SanKav Pharmaceuticals, has extensive experience in pharmaceutical business development, R&D, market formulations, testing, manufacturing, packaging, quality, regulatory compliance and submissions including product launches and commercializations. Dr. Gupta is a veteran and an entrepreneur and has been a strategic partner, consultant and expert advisor for key clients in the pharmaceuticals industry. He has the ability to lead scientists and project teams including regulatory, compliance, quality, clinical and business departments. Dr. Gupta specializes in selecting, developing and launching new products and associated services.
Interest & Experience
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Develop brand, 505(b)2 and generic projects in pharmaceutical drug delivery / technology and biologics areas of oral, topical, inhalation, nasal, parenteral and transdermal
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Provide services from early to late stage R&D, manufacturing & packaging of clinical supplies, quality management, regulatory, compliance, clinical programs, cGMP investigations and FDA submissions of new molecules or existing molecules in life cycle management.
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Introduced new drug products in R&D program
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Developed, scaled-up, and launched many ANDA (101+) and NDA (20 to 25) products.
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Directed staff of about 120 in R&D, portfolio and project management, product development (internal and external), R&D operations, biopharmaceutics, quality and regulatory affairs in submissions and technology.
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Licensed and Registered Pharmacist in New York State since July 1996
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Active Member of American Association of Pharmaceutical Scientists
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Drug Pricing and Business Management Course offered by Columbia University
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MIT Course on “Developing and Managing a Successful Technology and Product Strategy
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AAPS Course on “Challenges in Developing Biologics: Industry and Regulatory Expectations
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Essentials of a Global New Drug Application: Clinical, Non-clinical, and CMC Components
