cr.appliance is regularly involved in marketing authorisation processes and contributes respective scientific advice to pharmaceutical companies. In this capacity cr.appliance offers the following resources and services:
- Long-standing experience in preparation of and attendance at scientific advice meetings with regulatory authorities (FDA, EMA, BfArM, MPA, MHRA, TGA, etc.)
- Planning and preparation of scientific advice meetings with regulatory authorities
- Preparation of clinical sections of briefing documentations for scientific advice meetings
- Attendance and follow-up of scientific advice meetings