Hire Abhijit D. Gaikwad, a pharma consultant specializing in Analytical Testing, Clinical Studies, Drug Development and Pharmaceutical Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: Turkey
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Abhijit D. Gaikwad is a pharmaceutical formulation development professional with over 18 years of experience in product development, process optimization, scale-up, technology transfer, and commercialization. His expertise includes formulation development, oral solid dosages, process validation, stability programs, and development-related Chemistry, Manufacturing and Controls (CMC) and regulatory filing support. His background spans Carolina Pharmaceutical, Bilim Pharmaceutical, IPCA Laboratories, Macleods Pharmaceuticals, and Ajanta Pharma. He has worked across tablets, capsules, oral liquids, powders for reconstitution, and specialized dosage forms. Applying Quality by Design (QbD), Design of Experiments (DoE), and risk assessment, he helps pharmaceutical teams optimize formulations, execute pilot and exhibit batches, troubleshoot manufacturing processes, and prepare technical documentation for regulated-market product development. - Show More
Abhijit provides development-related CMC support across formulation development, manufacturing process optimization, scale-up, and technology transfer. His experience includes preparing Product Development Reports, Master Formula Records, Batch Manufacturing Records, risk assessments, and validation documentation. He helps teams document product and process knowledge to support regulated-market development and commercial manufacturing.
Abhijit supports pharmaceutical formulation development through pre-formulation studies, drug–excipient compatibility assessments, formulation screening, and optimization. His experience covers solid, liquid, and specialized dosage forms. He applies QbD, DoE, and risk-based approaches to development challenges and supports scale-up, technology transfer, and troubleshooting as products progress toward commercial manufacturing.
Abhijit supports the development and optimization of tablets, capsules, bilayer tablets, granules, and dry powder formulations. His experience includes formulation trials, process optimization, and execution of pilot, exhibit, and bioequivalence batches. He also supports manufacturing processes involving granulation, compression, coating, extrusion, and spheronization, helping teams address technical challenges during scale-up and transfer.
Abhijit supports pharmaceutical process validation through process development, critical process parameter evaluation, and preparation of validation protocols and reports. His experience includes scale-up, technology transfer, and manufacturing troubleshooting for finished dosage forms. He works with production and quality teams to support reproducible manufacturing processes and document validation activities during product commercialization.
Abhijit supports regulatory filing activities through preparation of formulation and manufacturing documentation, dossier support, and responses to regulatory queries. His experience includes submissions for US, European, domestic, and emerging markets. He coordinates with regulatory, analytical, and quality teams to provide development reports, manufacturing records, validation documentation, and stability information supporting submissions.
Abhijit supports stability studies during formulation development through stability evaluations, preparation of protocols and reports, and compilation of stability data. His experience includes assessing formulations during development and coordinating with analytical and quality teams. He helps teams organize stability information to support formulation optimization, product development decisions, and regulatory documentation.
