With our strap line 'the application of strong scientific understanding' the Scientific Advice procedure, with all that it means for drug development, is an aspect of regulatory affairs which is obviously very close to our heart.
Scientific Advice is a timetabled European procedure which can seem complicated and time consuming for clients who are not familar with it. There is no direct equivant in the USA. Scientific Advice progressed via the Scientific Advice Working Party (SAWP) of the European Medicines Agency, begins with a letter of intent 2 months prior to the Day 0 ''start of procedure'' (if an optional presubmission meeting is elected, or one month if a presubmission meeting is not required). It then takes a further 40 days for a Decision, or 70 days in cases which require further discussion to resolved points of contention.
BioVentures Consulting Limited can work with you to develop the key scientific issues for discussion and help formulate the questions, priorities, running order and timing of each item
BioVentures Consulting Limited can explain how to incorporate Scientific Advice within a global regulatory strategy.
We can work with you to provide an overview of the options available in the EU (national and CHMP), including the design of the optimal European strategy and when you should seek advice and / or a presubmission meeting.
BioVentures Consulting Limited can work with you to develop the key scientific issues for discussion and help formulate the questions (phrased and worded in a manner appropriate for European agencies), prioritise questions, running order and timing of each item. BioVentures Consulting Limited can help refine the briefing package in response to the List of Comments received from the EMA following the presubmission meeting. We can lead the rehearsal meeting, provide critical feedback and facilitate discussion for maximum benefit. Equally important, BioVentures Consulting Limited can advise on action to take following the Scientific Advice meeting, and help with implementation of key actions required for successful drug development.