A crucial part of getting your drug to market

Discussions with regulatory authorities can be held at any time of the drug development process. National European authorities, EMA, FDA and PMDA (Japan), for example, offer different kinds of scientific advice meetings to respond to specific questions by the drug developer.

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.

How to begin? A first meeting is a good start 👇

Contact our director of Regulatory Affairs

Send your inquiry to Erika Spens

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