Clear, accurate documentation can make the difference between approval and delay. Our regulatory and medical writing experts support you across every stage of the product lifecycle,
Helping you anticipate authority expectations and deliver submission-ready content with confidence. Whether you're preparing regulatory filings, scientific publications or patient-facing materials, we bring clarity, consistency and compliance to every word.
Why choose Clinigen
- Global writing team with deep regulatory and scientific expertise
- 30+ years’ experience with complex, multi-jurisdictional submissions
- Aligned to your style, timelines and authority requirements
Our expertise includes
Regulatory and medical writing
- Briefing documents for scientific advice and agency meetings
- IND, IMPD and CTA documentation
- Regulatory responses to agency questions
- Risk management plans
- Clinical study reports (CSRs)
- Lay summaries of trial results
- Investigator brochures and protocol amendments
- Patient narratives
- Development and periodic safety update reports (DSURs, PSURs)
Paediatric Investigation Plans (PIPs/iPSPs)
- Authoring of PIP and iPSP documentation (EU, UK, US)
- Alignment with wider regulatory strategy
- Authority-specific formatting and guidance compliance
Dossier development
- Clinical and nonclinical module writing (2.4 to 2.7)
- Chemistry, Manufacturing and Controls (Module 3)
- Core Data Sheet (CDS), SmPCs and PILs
- Product information and labelling
- Country-specific formatting and ePublishing
Medical and scientific writing
- Protocols and protocol amendments
- Literature reviews and summaries
- Manuscripts, abstracts, posters
- Medical information content
- Scientific communications and review articles
Chemistry, Manufacturing and Controls (CMC)
- Authoring of CMC sections from raw data
- Specification and validation documentation
- Environmental risk assessments (EU/UK)
- eCTD-ready formatting and publishing
Ready to make your submission stronger?
Partner with our regulatory and medical writing experts to plan, draft and quality check submission-ready documents aligned to authority guidance and timelines.