Nirav Modh
Deputy Manager at Alembic Pharmaceuticals Limited
Based in Vadodara, India
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Seniority
Manager
Department
Operations
Location
Vadodara
Industry
Pharmaceutical Manufacturing
Company size
14K
Contact information
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n•••••••@••••••.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Nirav Modh
I am a versatile & Dynamic Regulatory Expert in Pharmaceutical Field having 12 years of experience in regulatory affairs CMC, with a specialization in injectables and drug device combination products. Currently serving at Alembic Pharmaceuticals, handling complex injectables including peptides, and ophthalmics ANDA for the US market. Demonstrating a strong skill set in regulatory affairs CMC, including expertise in preparing pre-IND meeting requests, briefing packages, IND and 505(b)2 submissions, ensuring regulatory compliance and attention to detail. Proficient in the regulatory requirements of the regulated & emerging markets (US, CA, ROW) with a deep understanding of ICH guidelines and registration dossiers in CTD and eCTD format. Having hands on experience in publishing suite (eCTDXpress and Pharmaready) and troubleshooting. Providing leadership & consulting to maintain compliance with constantly changing domestic & international regulations as well as management of state/local license.
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