Regulatory Affairs
- Regulatory Filing – Regulatory Filing Strategy, Document Preparation and Reviews
- Regulatory Compliance Issues – Response Strategy and Response Drafting/ Preparation/ Review, Issue Resolution Plan
The world is divided in the drug approval procedures, it is important for the pharmaceutical product manufacturer, particularly the generic product manufacturer, to carefully assess the market interest, cost of product development, target markets/ regions, their corresponding regulatory requirements even before the development of a pharmaceutical product is initiated.
It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and its extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions. This helps in optimizing the overall efforts in: (a) pharmaceutical product development by eliminating unnecessary studies, (b) reducing the product launch to market time by avoiding extensive and multiple regulatory queries on development, thus reducing overall cost of research and development.