clinirx
CliniRx has a dedicated, in-house regulatory department
- Expedite the compilation and submission of clinical trial application
- Prepare Clinical trial authorizations dossiers
- Produce a submission acceptable to applicable regulatory authorities
- Facilitate regulatory review to achieve faster regulatory approval
- Drug import and export licensing
- Post submission support (e.g., annual reports, amendments, variations)
- Final Report preparation and submissions
- Marketing authorization dossiers (e.g., NDA, MAA, dossiers in CTD format)
- Regulatory Compliance Audits