Nirav Sheth
Senior Manager at Nivagen Pharmaceuticals, Inc
Based in Ahmedabad, India
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Seniority
Manager
Department
Manufacturing & Production
Location
Ahmedabad
Industry
Pharmaceutical Manufacturing
Company size
111
Contact information
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n•••••••@nivagen.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Nirav Sheth
Initiating my career as a generic drug programmer for the ROW (Latam & GCC) and Europe Market, I have predominantly worked for the US market for both solid oral and injectable formulations. At present, I spearhead the Regulatory Team, responsible for US Regulatory Market Operation encompassing Development, IND, NDA, ANDA Submissions, Deficiency Responses Review, Approvals, and Post-Approval Activities for the entire Injectable Portfolio using the ACE Model (Application Quality, Communication Effectiveness between FDA-Applicant, Efficient Review). I endeavor pharma companies with US regulatory market operations and generic drug life cycle management for injectable formulations to obtain first-cycle approval. I’m grateful to my professional mentors, peers, and team members for inspiring me to evolve into a better RA professional.
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