A well-structured team of professionals, with significant experience within the pharmaceutical sector, co-ordinates with regulatory agencies, they play a very important part within the organization. Internally it liaises at the interphase of drug development, manufacturing, and marketing. Externally the department is the key interface between the company and regulatory authorities.
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, Handling of queries, inquiries, onsite pre-approval inspections and renewal inspections by respective agencies. Data collected from the respective 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 and other regulatory submissions to various health agencies.
Giving strategic and technical advice to relevant departments, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.