Overall 22 years of Quality Assurance, Regulatory Affairs and Pharmacovigilance industry experience in both Pharmaceutical (Rx, OTC, Dietary Supplements, DEA) and Biotechnology fields.Expertise: Regulatory Affairs (Pre-approval and Post-approval): Regulatory Strategy, ANDA submissions, Handling of Deficiencies-CMC, Bio, Labeling, Post Approval changes: Handling of Supplements-CBE, PAS, Annual Report, Communication with FDA, Due diligence. Total ANDAs filed over 50 ANDAs as on date (Solids-Tablets and Capsules, Liquids-Solutions and Suspensions, Powder for Oral Solution, Parenteral, Extended-Release Dosage Forms); eCTD publishing tools handled--Docubridge, Extedo; easy eCTD; other regulatory activities-Drug Establishment Registration; Drug Listing; SPL; Review and Submission of US Drug Master Files (DMF).Quality Assurance: Manufacturing Assurance, Validation-Equipment, Utility and Process, Training, Documentation, Audits-Raw Materials, CMO and Packaging Vendors/C&F Audits, Hosting of FDA, DEA and UL Audits, Market Complaints; Quality Agreements; Quality Metrics; Drug Licenses; Tools handled--SAP, AEGIS, Track wise, MicrosoftPharmacovigilance: Adverse event report submission to FDA; Hosting FDA ADE Audit; SDEA-Safety Data Exchange Agreements; Submissions through FDA’s SRP-Safety Reporting Portal; Handling of customer inquiries.