Mr. Sinha

Mr. Sinha obtained his Bachelor of Science degree in Biology from University of North Carolina. He further received his Postgraduate Diploma in Pharmaceutical Sciences from University of Sydney. Mr. Sinha started his career in regulatory affairs in 2005, worked as a highly motivated, results-oriented Regulatory Affairs Consultant and Project Management Professional accumulating over 15 years of experience in the the field of Generics, Pharmaceuticals, and Consumer Health. He has working knowledge of cGMP, ISO, EU guidelines, FDA requirements for API, DMF, CEPs, IND/CTA, (A)NDA, MAA, BLA, IMPD, and CPPs.

Mr. Sinha spent more than 3 years working as Associate Director of Regulatory CMC and as a CMC Consultant for Biologics and Small Molecules at PDD. He provided services in CMC regulatory consulting, product lifecycle management, gap analysis for various phases of CMC submission dossier (IMPD and IND) for submission to EU and USA. He also authored and reviewed of 10 INDs/IMPDs and DMFs.

Areas of special expertise:

  • Project Lifecycle Proficiency
  • Strategic Planning/Analysis
  • Technical Services
  • Process Improvements
  • Tactful Communications
  • Validation / Manufacturing
  • Effective Leadership
  • Innovative Solutions
  • Time/Resource Management
  • Internal/External Liaising

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