Pharmaceutical Industry is one of the most regulated of all industries and therefore it is important for the Regulatory Affairs team to have a thorough understanding of pharmaceutical registration for each and every country.
Data collected from the various other departments such as R&D, manufacturing, marketing among others is assimilated and compiled for registering the company, products and for updating health authorities in various countries.
The Regulatory Affairs department at Bipha plays a very important part within the organisation. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally the department is the key interface between the company and the regulatory authorities. Data collected from the various other departments is assimilated and compiled for registering the company, products and for updating health authorities in various countries.
Our regulatory affairs team is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities.
Regulatory Affairs department is actively involved in every stage of the development process of a new medicine and in the post-marketing initiatives with respect to the authorized medicinal products.