To learn more specifics about our services, please don’t hesitate to contact us. Our medical writing services include the following:
Document Types
- Clinical study reports
- Clinical CTD summary documents for marketing applications
- Protocols, including special protocol assessments
- Investigator’s brochures
- INDs/IMPDs
- Regulatory responses
- Briefing packages
- Pediatric study plans/Pediatric Investigational Plans
- White papers
- PSURs/DSURs
- Risk management plans
- REMS-associated documents
Document Assembly
- CSR appendices
- Bookmarking/hyperlinking of documents
Quality Control Review
- Statistical data points (including tables and listings)
- Regulatory publishing readiness
- Consistency, cohesiveness, grammar, and style guidelines
Therapeutic Area Experience
Treatment Modality
Geographic Region
Contact us today to begin your project. We look forward to working with you!
