Prashant Swami

Background

About Prashant Swami

Regulatory Affairs- India (Domestic) Licensing Over 12 years of versatile, industrial experience in various areas of the pharmaceutical industry with such as Shreya Life Sciences PVT. Ltd.(WHO-GMP Approved); Genome Biotech (WHO-GMP Approved), Wockhardt Ltd (MHRA Approved). Wide exposure to Regulatory Affairs- India Licensing, Quality Assurance & Compliance areas in a pharmaceutical manufacturing environment. Regulatory Affairs- India Licensing experience in various dosage forms such as Tablets, Capsules, OraL Powder, SVP Injectable, Recombinant rDNA SVP Injectable and in API. Preparation & online application submission to Local FDA, State FDA and CDSCO on xlnindia & Sugam portal and manually. Co-ordination & Effective networking with the key Government Authorities for priority topics and Prepare, review and updation of PPIs, follow-up and getting approval in timely manner and ensure it meets the current regulatory requirements. Fully involvement in WHO audit, Sch M GMP audit, CDSCO – Risk based GMP audits. Proper communications, co-ordination, follow up & give feedback to concern dept regarding regulatory issues and reporting with details to Head of Department. To arrange governance meeting and track the actions status to bridge the gaps as per regulatory requirements. Evaluation of documents in line with current and day to day updated regulatory requirements. To review WHO- GMP TRS, GLP and Schedule M checklist and to verify the compliance as per the checklist.