Overview

The VMRC's Drug Regulatory Affairs (DRA) department ensures that all drugs manufactured by the company meet the necessary safety and quality standards. In order to do this, we keep up to date with the latest changes in regulations and regularly audit the manufacturing process. The department also provides regulatory guidance to the industry on the developing, manufacturing, and clinical testing of new products. The Drug Regulatory Affairs Department is essential to protecting the public from unsafe or ineffective drugs. The Drug Regulatory Affairs Department also works with other government agencies to ensure that medications are appropriately labeled and advertised. This includes ensuring that drug labels accurately reflect the risks and benefits of the drug.

Area of interest

• Dossier preparation & filing (DCG(I)/eCTD/Nees/ CTD/ACTD).
• Post-approval product life cycle support including variation application (Type IA, IB, II, Group), Renewal application, Risk management plan, PSUR (Authorizing and Submission Management), MA Transfer, Readability Assessment, CPP
• Take over and manage all phases of the market authorization procedure in EU: Decentralized procedure (DCP) in all EU member states, Mutual Recognition Procedure (MRP), National Procedure, etc.
• Conducting Pre-IND/NDA/Pre-NDS/Scientific Advice Meetings, submissions and any Postapproval Changes when required for the US.
• Scientific advice/consultation with regulatory authorities.
• Provide compliance to QP and Quality/Clinical/Nonclinical experts

Drug Regulatory affairs

Team Profile

Jatinder Singh Mahant

General Manager | Regulatory Affairs

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Dulichand

Assistant General Manager | Regulatory Affairs

Nitin Sharma

Senior Manager | Regulatory Affairs

Ankit Mittal

Assistant Manager | Regulatory Affairs

Bajrang Lal

Assistant Manager | Regulatory Affairs

Contact at: dgm.dra@venusremedies.com