Overview

Drug Regulatory Affairs refers to all aspects of the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety, and Efficacy as well as Health Authorities' attitudes and requirements, etc. have a great influence on the drug development process and the success of it.

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

Nitin Sharma

Senior Manager | Regulatory Affairs

Bajrang Lal

Assistant Manager | Regulatory Affairs

Contact at: dgm.dra@venusremedies.com