Confidence Beyond Compliance

Meetings with health authorities such as FDA in US, EMA in Europe or other national authorities have shown to increase the probability of a rapid market approval and can have a direct impact on development pathway and costs. Since authorities take the final decision to approve or reject products, it is highly recommended to optimize authority communication and to hold face to face and teleconference meetings all along the development pathway. But how do you get the best scientific advice or pre-submission meeting from a Health Authority? Authorities encourage to start discussions as early in the development process as possible so that sponsors can become aware of concerns and be able to address issues timely in their development program. Meetings at critical milestones during development have been shown to dramatically increase the probability of timely approval.

PharmaLex has extensive experience of leading clients through the Scientific Advice process, both with EMA and national authorities in the EU. Outside of the EU, PharmaLex has significant experience in engaging with the FDA (e.g. for pre-IND, End of Phase 1 or 2, pre-NDA or Type C meetings) via our US affiliate, as well as with several other international agencies, facilitated by our local country-based partners who are able to provide local procedural guidance and logistical support.

Our activities have usually involved all aspects of scientific advice including all the following:

  • Development of the strategy for seeking advice
  • Liaison with FDA / EMA or NCAs to manage the procedures
  • Identification of topics on which advice is sought
  • Development of appropriate questions in relation to each topic
  • Development of company positions and justifications in relation to each question
  • Authoring, compilation, and submission of briefing documents
  • Development of company presentations
  • Arranging and leading rehearsals with attendees from client companies
  • Acting as the company’s delegation head and attending authority meetings
  • Leading proceedings at meetings with the authorities including delivery of presentations on behalf of client companies; – Preparation of company minutes for submission and any follow-up interactions
  • Handling all logistical aspects in respect of document submission and meeting attendance
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