Regulatory Affairs

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.

• 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