• Committed Towards Better Healthcare
  • Committed Towards Better Healthcare
  • Committed Towards Better Healthcare
  • Committed Towards Better Healthcare
  • Committed Towards Better Healthcare
  • Committed Towards Better Healthcare

Regulatory Affairs

Drug Regulatory Affairs ( DRA )

Synokem has a dedicated team for Drug Regulatory Affairs ( DRA ) which is focused in approval of New Drugs, Subsequent New Drugs, FDC`s, Test Licenses, NOC`s & Registrations from CDSCO HQ. The team co-ordinates with highly qualified and experienced R & D team of the factory for development and preparation of data to be submitted the DCGI office for approvals.

A new Pharmacovigilance cell has also been formed as per guidelines framed by the Ministry of Health and is active for reporting ADR`s etc., in addition to preparation of PSUR`s. Synokem is privileged to be the First Company in India to be granted permission for manufacture and market Azilsartan and Dienogest.

Our Valuable Clients