Medical and Regulatory Writing
Comprehensive support across clinical and regulatory project initiatives
What we can do for you.
- Module 2 summaries (2.3, 2.4, 2.5, 2.6, 2.7.x) and overviews
- Clinical study reports, narratives, responses to queries
- Labeling and evidence alignment (annotated Labels)
- Reviewer’s guides and briefing packages
- iIBs, IBs and IB Updates
- Briefing Documents, BTD, ODD, FTD, pre-INDs
- Submission Dossiers-NDA, BLA, MAA, CTA, IMPD.
- Annual reports-DSUR, PSUR, PBRER
Clear, accurate, and compliant documentation is essential for successful health authority submissions. PrimePath Regulatory provides comprehensive Medical and Regulatory Writing support across all phases of development — from study protocols and clinical study reports to integrated summaries and Module 2 CTD documents. Our writers combine scientific precision with regulatory insight to produce persuasive, audit-ready documents that communicate your product’s value and meet global submission standards.
