Confidence Beyond Compliance
PharmaLex has considerable experience of leading clients through the Scientific Advice process, both with FDA & EMA (including major experience with national procedures in a number of EU Member States). Thorough understanding and a great network poses the bases of this service: MHRA (UK), BfArM (Germany), DHMA (Denmark), MEB (the Netherlands), and MPA (Sweden). Outside of the EU, PharmaLex has significant experience in engaging with the FDA (e.g. for pre-IND, End of Phase 1 or End of Phase 2 or Type C meetings) via our US affiliates, as well as with a number of 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 of the following:
- Development of the strategy for seeking advice;
- Co-ordination with FDA / EMA or NCAs to arrange the procedures;
- Identification of topics on which advice is sought;
- Developing appropriate questions in relation to each topic;
- Development of company positions and justifications in relation to each question;
- Development and submission of briefing documents;
- Development of company presentations;
- Arranging and leading rehearsals with attendees from client companies;
- Attendance at pre-submission meetings with FDA / EMA Scientific Advice secretariat;
- 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.