Understanding that well timed and professional Regulatory support can have significant role in the quick and smooth approval of pharmaceuticals, I can help you in following:
- Developing Global Regulatory Strategy
- Interacting with Authorities
- Preparing your team for authority meetings in the EU, USA and other regions/countries
- Coordinating Clinical Trials Applications in Europe
- Developing Pediatric Plans for Europe and USA
- Marketing Authorization Applications in Europe
- Preparing for Orphan Drug Designation applications
- Writing and/or reviewing submission documents
- Training/coaching on Regulatory matters
- etc.