Data-driven, reliable and global, our regulatory affairs team can help you to meet your targets.
Located strategically across the US and Europe, our regulatory affairs teams are well-positioned to offer global regulatory consulting and complete lifecycle management from early clinical development to clinical trial submissions and marketing authorizations.
Ergomed is a trusted partner and an integral member of our clients’ regulatory and clinical development teams. Our regulatory intelligence and data-driven methodology, combined with unparalleled attention to detail, means we offer an accurate, first-time approach.
Our regulatory affairs teams can support the preparation of all major regulatory dossiers, including complex multinational submissions, while our regulatory project management oversight covers the quality control review of each document.
Our regulatory affairs teams covers:
- Clinical trial authorization/application/exemptions (CTA/CTX)
- Clinical trial notifications (CTN)
- Common technical document (CTD)
- Investigational drug exemptions (IDE)
- Investigational new drug applications (IND)
- Marketing authorization applications (MAA)
- New drug applications (NDA)
- Biological License Application (BLA)
- Abbreviated new drug application (aNDA)