Regulatory Support
Accelera has the experience and expertise to provide regulatory support services required throughout the drug development process.
- Investigational New Drug (IND) preparation
- Clinical Trials Application (CTA) preparation
- Investigator Brochure (IB) preparation
- Investigational Medicinal Product Dossier (IMPD) preparation
- Review of Sponsor-prepared documents
- Due diligence review, gap analysis review