Global Regulatory Affairs Consulting provides comprehensive strategic and operational services to the pharmaceutical and biotech industries covering all territories. Our expertise includes Advanced Therapy Medicinal Products (ATMPs), technically and scientifically advanced therapies, vaccines, large and small molecules, biotech and pharmaceuticals. With more than 27 years experience in regulatory affairs, we have the experience and expertise to provide intelligent regulatory solutions that deliver the results you expect. Services include: 1. Regulatory strategy definition and implementation 2. Due diligence 3. All regulatory procedures - MAA, BLA, NDA, NDS, CTA, IND 4. Scientific Advice and Protocol Assistance 5. Briefing Packages, rehearsals and facilitation of Agency meetings 6. Writing, review and submission of eCTD documentation to Agencies 7. Post-approval portfolio lifecycle management - CMC and labelling variations 8. Orphan Drug Designation Applications 9. Paediatric Investigational Plans (PIPs) 10. Geographic expansion and Early Access Programs (EAPs) 11. Global program, project and interim management 12. Tender preparation and submissions 13. SME designation requests and renewals 14. Assistance in starting up organisations in new territories charmaine@gra-consulting.nl +31 (0)642 30 78 67 (mobile)