RPI provides technical and medical writing and editing services for regulatory submissions in eCTD format. RPI’s Document Preparation Services include:
- Regulatory / Health Authority Submission Documents for FDA and EMA
- Regulatory Review – consistency of message, regulatory commitments
- Clinical Documents – support for labeling
- Document QC – data integrity
Examples of Regulatory Document Services:
- IND, NDA and MAA Modules (2.4, 2.5, 2.6, 2.7)
- Investigator’s Brochures
- Pre-INDs
- DSURs
- Regulatory Responses
- Pediatric Plans
- ISS/ISEs
- Briefing Books
- Lay Summaries (EU)
- Health Authority Meeting Materials
Examples of Clinical Document Services:
- Protocols
- Protocol Amendments
- Clinical Study Reports
- Annual Reports
- Narratives
- Executive Summaries