Regulatory & Medical
Regulatory Affairs
Submissions, meetings and approvals with the FDA, EMA and other health authorities, for as long as your program needs them.
What's Included
- FDA submissions: IND, amendments, annual reports, DSUR, clinical hold responses
- Health authority meetings: pre-IND, INTERACT, Type A/B/C, scientific advice
- Clinical trial applications: SFDA, EMA/CTIS, MHRA, Health Canada, ANMAT, TİTCK and other authorities
- IMPD and CMC dossiers in eCTD format, with publishing and lifecycle management
- Expedited program and designation requests (Fast Track, Breakthrough, RMAT, Orphan, PRIME)
- Marketing application support (NDA, BLA, MAA) and module writing
- Ethics and bioethics submissions (IRB/IEC, NCBE)
- Import/export permits and licenses for IMP and biological samples
- Regulatory intelligence and country requirement assessments
- Labeling and IMP label compliance