A well-structured team of professionals, with significant experience within the pharmaceutical sector, coordinates regulatory affairs, they play a very important part within the organization. Internally it liaises at the inter-phase of drug development, manufacturing and marketing. Externally the department is the key interface between the company and the regulatory authorities.
The RA department takes care of managing regulatory submissions and amendments; communications with Regulatory Agencies (USFDA, EU etc.) as well as continual training in the regulatory requirements. The team has a strong track record of dealing with variations, additional requests, enquiries, onsite pre-approval inspections and renewal inspections by respective agencies.Data collected from the various other departments is assimilated and compiled for registering the company’s products and for updating health authorities in various countries. The team is also able to smoothly handle DMFs, ANDAs, and other regulatory submissions.