Hire Dr. Sanjay Shukla, 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 Shukla is an experienced API/CDMO R&D leader with deep expertise in API Process Development, Chemistry, Manufacturing and Controls (CMC), Regulatory Filing, and Process Validation. His career spans synthetic route design, process optimization, scale-up from laboratory to multi-ton commercial manufacturing, technology transfer, impurity profiling, genotoxic impurity control, polymorph management, and development of cost-efficient, patent non-infringing processes. He has contributed to the development of more than 100 APIs and intermediates and has extensive experience with ICH Q3A/Q3B/Q11/M7 requirements, DMF/CEP/EDMF documentation, USFDA/WHO-regulated markets, and CDMO programs for global pharmaceutical companies. His strong synthetic chemistry background, coupled with commercial-scale process development and regulatory knowledge, enables him to support pharmaceutical organizations from early API route development through successful manufacturing transfer and regulatory submission. - Show More
This is Dr. Sanjay Shukla’s strongest service. He has extensive experience designing and optimizing synthetic routes for APIs and complex intermediates, including reaction screening, process robustness studies, yield improvement, solvent optimization, impurity control, cost reduction, and process intensification. His work spans laboratory development, pilot-scale execution, and multi-ton commercial manufacturing, with experience across more than 20 reaction classes and over 100 APIs/intermediates.
Dr. Sanjay supports CMC activities through extensive experience in API process chemistry, impurity profiling, critical process parameters, critical quality attributes, polymorph control, specification development, technology transfer, and regulatory documentation. His expertise includes ICH Q3A/Q3B/Q11/M7 requirements and development of scientifically justified impurity-control strategies, enabling him to support the CMC aspects of API development and regulated-market submissions.
Dr. Sanjay has strong experience transitioning API processes from R&D through pilot scale to commercial manufacturing. His background includes technology transfer, commercial trial batches, BPR review, process-validation documentation, manufacturing readiness, and establishment of scalable, robust operating conditions. He can support organizations in developing validation-ready processes and successfully transferring technologies into commercial manufacturing environments.
Dr. Sanjay has significant experience supporting regulatory filings for APIs intended for regulated markets. He has authored technical sections of DMFs and worked with USFDA, WHO, and EDMF submission formats, including impurity justifications, GTI control strategies, process descriptions, and technical documentation. His development work has supported several APIs intended for USFDA and other regulated markets.
