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Hiral Gutka

Regulatory Affairs Specialist @ Zimmer Biomet

Hiral Gutka Contact Details

Dover, Ohio
Regulatory Affairs Specialist @ Zimmer Biomet
Regulatory Affairs Associate @ Zimmer
Regulatory Affairs Specialist-CMC @ Syner-G Pharma CMC Consulting, LLC
Bachelor in Pharmacy, Pharmacy @ Dr. B. N. College

• Familiarity with US Federal Regulations and Guidance governing drug and device development (IND, IDE, NDA, ANDA, Orphan Drug designation, BLA, PMA) • Application of current CMC guidance (Drug Substance, Drug Product, Stability, Impurities in Drug Substance/Drug Product) and knowledge to ensure regulatory compliance for Investigational Products • Application of CMC guidance (Changes to an approved NDA 

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