Devendra Patel
Regulatory Affairs Associate @Nivagen Pharmaceuticals, Inc.
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Affairs Associate @Nivagen Pharmaceuticals, Inc.
Sacramento, CA, US
Follow up with cross functional teams, collection and final Review of documents for regulatory submission. To support compilation of pdf documents, its assembling and quality review in electronic (eCTD) format. Compilation & review of PIND, NDA (505b2), ANDA submission of dosages form (Parenteral) Keep up-to-date with changes in regulatory guidelines and sharing with colleagues. Compilation and review of deficiency responses for Original ANDAs. Post approval supplements/Variations filing, CBE0, CBE30, PAS. Technical Review of all the CMC documents. Module 1, Module 2, Module 3 Authoring for ANDA, PFC and supplements/Variations submission. Product life cycle management. Regulatory Inspection readiness verification.
EDUCATION
Shivaji University, Kolhapur
M.pharm, Quality Assuarance
Shivaji University, Kolhapur
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
ABOUT DEVENDRA PATEL
I have more than 15 years of experience as a Quality Assurance and Regulatory compliance…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.