Nirav Modh Email & Phone Number

Vadodara

Complex Injectables including Peptides, ophthalmic suspension/solution and emulsion

Ahmedabad, Gujarat, India

- Compilation and finalization of ANDA and 505(b)2 submission for injectables and drug device combination. - Involved in preparation of PIND meeting request, Briefing package, clarification questions and subsequent IND submission. - Compilation and finalization of IND and subsequent 505(b)2 submission package. - Preparation of White paper, Controlled.

Ahmedabad, Gujarat, India

 Steered efforts in preparation, compilation and submission of ANDA and ANDS through ESG with complete life cycle management.  Review of technical documents for regulatory submission. Finalization of post approval submission packages, archival of regulatory correspondence and regulatory database updation. Coordinated activities within cross-functional.

Ahmedabad, Gujarat, India

 Compiled CTD and country-specific registration dossiers for solid oral dosage forms, evaluated queries from regional agencies, and provided timely responses by compliance of ICH requirements. Transferred registration and variation details to manufacturing facilities for ease of commercial launch, handled post-approval submission packages, and archival.

Ahmedabad, Gujarat, India

 Prepared and compiled country-specific registration dossiers in ASEAN CTD format, coordinated with cross-functional teams for timely availability of technical documents and finished product samples. Provided necessary information for the development of country-specific artwork, assisting in the application of product permissions, COPP, FSC and WHO-GMP.

B.Pharm, Pharmaceutical Science, First Class

M.Pharm, Pharmaceutics And Drug Design, First Class

Pgdra, Regulatory Affairs, Distinction

H.S.C, Science, Distinction

94%

Mba, International Business, Distinction