Ajay pal Sharma

Writes/reviews high-quality CMC documentation during development and product registration, respecting agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.

Prepared CMC documentation for drug product registration through National Procedure/ MRP and DCP in EU.Responded queries (Quality) raised by various EU Regulatory Agency while the assessment of dossier through National Procedure/ Mutual Recognition Procedure/ Decentralized Procedure.Working knowledge of Type I (A&B) and Type II complex variation based on the requirement of manufacturing and compliance and responded to the queries raised during their assessment procedure in EU.

Worked on HPLC method development and method validation for assay, related substances and dissolution method development studies of drug products and drug substances. Prominently involved in the Analytical Method transfer at sites in the United States for the settlement of FDA queries. HPLC analytical method development. Validation of HPLC analytical methods fulfilling ICH and USFDA guidelines. Development of analytical methods and validating the same for formulations for Para IV and EU submission