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 30 years experience in regulatory affairs, we have the experience and expertise to provide intelligent regulatory solutions that deliver the results you expect.
Regulatory strategy definition and implementation
All regulatory procedures - MAA, BLA, NDA, NDS, CTA, IND
Scientific Advice and Protocol Assistance
Briefing Packages, rehearsals and facilitation of Agency meetings
Writing, review and submission of eCTD documentation to Agencies
Post-approval lifecycle management - CMC and labeling variations
Orphan Drug Designation Applications
Pediatric Investigational Plans (PIPs)
Geographic expansion and Early Access Programs (EAPs)
Global program, project and interim management
Tender preparation and submissions
SME designation requests and renewals
Assistance in starting up organisations in new territories
Charmaine Augustinus-Lever B Pharm, Hons B Com, MBA, MTOPRA
Mambostraat 15,1448VD Purmerend,The Netherlands
Telephone +31 (0)642 30 78 67