- Position papers and regulatory strategy roadmaps
- Implementation of innovative and streamlined global development plans
- Gap analysis and due diligence of regulatory documentation
- Preparation and submission of regulatory files: follow-up with regulatory Authorities
Regulatory submissions include:
- Orphan Drug Designations. Voisin Consulting Life Sciences can act as an orphan drug designation Sponsor in the USA, Europe and Switzerland
- Clinical Trial Applications in Europe and Investigational New Drug applications in the USA
- Pediatric Investigational Plans
- Marketing applications in Europe, the USA and ASEAN region under CTD and eCTD/NEES in accordance with local requirements
- Life Cycle regulatory submissions: Variations/Supplements, Extensions and Renewals
- Meetings with regulatory agencies including Scientific Advice/pre-MAA meetings in the EU, pre-IND, End of Phase 2 and pre-NDA/BLA meetings in the USA
