Hire Dr. Sanjay Tiwari, a pharma consultant specializing in Clinical Studies, Drug Development and Pharmaceutical Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dr. Sanjay Tiwari is a pharmaceutical formulation and R&D professional with over 19 years of overall experience, including more than 15 years in formulation research and development. He has contributed to the development and submission of over 50 pharmaceutical and nutraceutical products, with experience supporting regulated markets including the US, EU, and Canada. His expertise covers formulation development, oral solid dosages, Chemistry, Manufacturing and Controls (CMC), regulatory filing, and process validation. His background includes roles with Leumas–Fermedicius Labs, Simpex Pharma, Biocon, Glenmark, Alkem, and other pharmaceutical organizations. He supports product development from concept through scale-up, technology transfer, and commercialization, alongside lifecycle management and formulation-related regulatory responses. He holds a Ph.D. in Pharmacy and an M.Pharm. - Show More
Sanjay supports formulation-related CMC activities for pharmaceutical development and regulatory submissions. His experience includes aligning formulation and manufacturing information with submission requirements for the US, EU, and Canada. He works with analytical, production, QA, and regulatory teams to prepare technical information, address development queries, and support CMC documentation throughout product development and lifecycle management.
Sanjay supports pharmaceutical and nutraceutical formulation development from initial concept through commercialization. His experience includes powders, granules, tablets, capsules, pediatric powders, protein mixes, and liquid orals. He assists with formulation optimization, scale-up, and technology transfer, coordinating with analytical, manufacturing, quality, and regulatory teams. His background also includes nutraceutical development aligned with FSSAI requirements.
Sanjay provides development support for oral solid dosage products, including tablets, capsules, powders, and granules in sachets. His experience covers formulation research, exhibit batch execution, process optimization, and transfer to manufacturing. He helps organizations address development challenges and coordinate the technical activities needed to progress oral solid products toward submission and commercial production.
Sanjay supports process validation through experience executing validation batches, scale-up activities, and process optimization for developed formulations. He works with manufacturing, quality, and development teams to translate laboratory processes into production operations. His support focuses on reviewing manufacturing performance, addressing formulation-related process challenges, and coordinating technical inputs during validation and technology transfer.
Sanjay supports regulatory submissions through formulation documentation and technical responses to deficiency queries. His experience includes ANDA submissions, CBE-0 and CBE-30 supplements, and filings for European, Canadian, and other markets. He helps teams prepare formulation-related responses and shares lessons from regulatory queries across development, plant, and analytical functions to improve subsequent submissions.
