Regulatory Submissions
Accelagen have prepared and submitted a large variety of regulatory applications, including:
- New chemical or biological medicines
- Generic applications
- Device/IVD Inclusion Applications
- Orphan Drug Designations (ODDs)
- Investigational New Drug (IND) applications
- Investigational Device Exemption (IDE) applications
- Quality or Clinical variations
- Self-assessable notifications
- Annual Reports
- Clinical Trial Notifications
Accelagen have developed various templates to prepared documents in accordance with ICH Common Technical Document (CTD) for medicine application and the IMDRF Technical File formats.