Amit Chavan
Regulatory Affairs Professional
- Role
- Associate Regulatory Affairs at Fresenius Kabi
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Amit Chavan
Authoring, Compilation and Review of module 1, module 2 and module 3 sections for New MAA and LCM of Solid orals (Tablets & Capsules) and Liquid dosage forms for UK & Europe Market- Evaluation, Compilation, review and ensuring timely submission of agencies query responses- Review R&D documents like MFR\'s, MPR\'s, API and FP Specifications and STPs, etc and QA documents like BMR\'s, BPR\'s, Specifications, COAs, Validation Protocols and Reports, Stability protocols, Stability Data etc- Review of drug products labellig- Processing of pdf files by using Adobe Acrobat for sequence compilation in eCTD format- eCTD compilation, verification and submission publishing activity by using electronic tools.
Experience
Associate Regulatory Affairs
Jul 2024 — Present · IN
Education
MIT World Peace University
Post graduate diploma course
2021 — 2022
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