Ashutosh Prakash
Regulatory Professional with an understanding of INDs ANDAs NDAs & 505b(2)), 10(1), 10(3) and Renewal application. Various types of Post Approval supplements. Briefing documents for FDA meetings.
- Role
- Deputy Manager at Endo
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Ashutosh Prakash
Regulatory Professional with an understanding of ANDAs, NDAs & BLA (including 505b(2))…
Experience
Deputy Manager
Aug 2021 — Present · Navi Mumbai, IN
Regulatory Professional with an understanding of ANDAs, NDAs & BLA (including 505b(2)) application, Various types of Post Approval supplements. Briefing documents for FDA meetings, with a focus on regulatory and CMC sections, Regulatory support during early development phase of NDA/ ANDA/BLA by designing regulatory strategies including high barrier generics and improved versions of approved molecules. Also, expert in maintaining life cycle management of NDAs, ANDAs ensuring high quality of submission, and facilitate ease of review at FDA resulted in first cycle approvals. Expert in resolving 80-day marketing exclusivity regulatory challenges by FDA and by competitors, Directed regulatory filing due diligence audits. Develop Regulatory Filling Strategies in support of new fillings, pending application & approved application.
Education
Poona College of Pharmacy, Pune
Bachelor of Pharmacy - BPharm
2000
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Master of Pharmacy
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