REGULATORY AFFAIRS

Regulatory Affairs Department : The Key Liaison Point
Regulatory affairs department of Gracure works as a key liaison between the pharmaceutical company and the governmental regulatory bodies, ensuring that all the necessary requirements are met and the products are approved as soon as possible.

Initial Study
The department identifies input required into the choice of both the nature and number of studies, pharmaceutical, analytical, pre-clinical and clinical which are required to support the eventual filing.

Compliance Issues
It thoroughly looks after source of API to ensure its quality, pharmacopoeial Compliance of API / DP / Excipients, patent situation in the importing country, stability data, bio-equivalence, analytical and manufacturing process validation

Concluding Development Program

As the development programme of studies draws to its conclusion, the regulatory department makes the necessary preparations for the filing, advising on the most advantageous filing strategy, alerting the necessary authorities that filing is imminent, and compiling the application itself. This compilation involves blending information, generated by a number of different departments either within the company or by external contractors, into a coherent, logical, consistent submission.

Response to queries

The department is the primary contact for all queries and questions from the agencies, and co-ordinates responses with the relevant internal departments. It manages the production of responses and clarification or justification for the scientific arguments used to support the application.

Post Approval

However, regulatory affairs doesn't just stop after a successful approval. It maintains the existing marketing authorisations, compiling and submitting so-called variation applications to update authorisations as a result of modifications and amendments to manufacturing processes, extending product indications as a result of additional clinical trials, updating product literature and labelling, and filing renewals.