Regulatory Affairs
At Oricent, we know that regulatory compliance is critical to every study from providing you with country selection/regulatory timeline guidance, preparation and submission management of clinical trial applications to compliance support in auditing and training services that will help ensure regulatory compliance of your clinical program.
Services:
- Country selection/regulatory timeline guidance
- Preparation, submission maintenance of clinical trial applications
- Independent Review Board (IRB/IEC) Audits
- Trial Master File Audits
- Final Clinical Study Report (FCSR) Audits
- Medical/technical writing
- Database Audits
- Vendor Audits
- ICH/GCP training
- Investigator Meeting ICH/GCP Compliance Training
- Pre-FDA/Regulatory inspection site preparation
- Compliance review of Essential Documents for IMP release
- QA Compliance Consulting