Mr. Sinha

Principal CMC consultant and writer

Mr Sinha obtained his Bachelor of Science degree in Biology and MS in Pharmaceutical Sciences. Mr Sinha has more than 20 years in regulatory affairs, worked as a highly motivated, results-oriented Regulatory Affairs Consultant and Project Management Professional with dedicated experience within the pharmaceutical industry, including fields of Generics, Pharma, and Consumer Health. HS has sweeping knowledge of Regulatory Affairs, Technical Services, CMC writing, validation, and manufacturing, and working knowledge of cGMP, ISO, EU guidelines, FDA regulations, API, DMF & CEP, eCTD, IND, A/NDA, MAA, BLAs, IMPD/CTA, CPP and regulatory guidelines of USA as well as global markets.

Mr Sinha spent more than 3 years working as Associate Director of Regulatory CMC and CMC Consultant in Biologics and Small Molecules to provide regulatory consulting, product lifecycle management, gap analysis for various phases of CMC submission dossier (IMPD and IND) for submission to EU and USA. HS also authored and reviewed of 10 INDs/IMPDs, M3, and DMFs.

Expertise:

• Project Lifecycle Proficiency
• Strategic Planning/Analysis
• Technical Services
• CMC writing of documents in M3 and M2.3
• Process Improvements
• Tactful Communications
• Validation / Manufacturing
• Effective Leadership
• Innovative Solutions
• Time/Resource Management
• Exceptional Leadership
• Internal/External Liaising

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