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, Import Registrations and Import Licenses 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. The team also coordinates with different CRO’s to conduct BA / BE studies and CT studies as per requirements of the DCGI’s office. Regular Audits are conducted at the various sites to see the proper functioning of the trails / studies.
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, Dienogest, Ulipristol Acetate & Azelinidipine.