Preparation and interpretation are highly important when communicating with regulatory bodies. The questions you ask at a meeting with regulatory bodies can relate to the pre-clinical, clinical and quality aspects of the development project. It’s all about optimizing the opportunities for advice and getting on the same page with the regulatory authority.
What we do
- We can help you to decide which agency (or agencies) is the most beneficial to approach and build relations with.
- We help to decide the proper time for the meeting. As well as scheduling all other points of contact with the agency.
- Defining questions to ask, preparation of the briefing document and meeting presentation.
- We can organize meeting rehearsals together with the drug developer.
- On your behalf, we can take lead in the meeting with the regulatory bodies to make sure you go in the right direction.
- After the meeting, we help you to interpret the responses from the regulatory bodies, prepare meeting minutes and identify the next steps.