Regulatory Writing

We have experience authoring a variety of regulatory documents across a wide range of therapeutic areas. We have authored many clinical study reports (CSRs), clinical protocols, Investigator Brochures, and components of Investigational New Drug (IND) applications. We have also written portions of marketing applications.

State-of-the-Art Services

We can guide you through the jungles of regulatory documents and ensure regulatory success for your programs.

Our services include:

• Protocol writing
• CSR PK/PD sections
• TK Reports
• IND sections
• Investigator's Brochure (IB)
• NDA/BLA sections (all modules)
• CTAs, BE Biowaivers
• Pediatric Investigational/Study Plans (PIP/PSPs)
• eCTD publishing and submission support
• CTD / eCTD Modules 1 to 5
• Briefing documents
• PK/PD, TK, and population PK reports