Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing.
The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.
1. Drug Registration
2. Preparation of Common Technical Document (CTD)
3. Preparation of Electronic Common Technical Document (eCTD)
4. Preparation and updating of Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC).