Clinical and Regulatory Writing Support

We have been writing a full range of regulatory documents for our global and local clients since 2005. By generating high-quality documents that follow the ICH and regional guidelines, we have supported our clients’ global regulatory submissions, as well as their business collaborations.

From developing a study protocol to writing a final study report, from updating an investigator brochure to summarizing the efficacy and safety of multiple studies, from managing references to fact-checking contents, we are here to help.


  • Protocols
  • Clinical study reports
  • Patient narratives
  • Investigator brochures
  • Clinical summaries
  • Clinical trial reporting
  • FDA advisory board meeting preparation
  • Clinical and regulatory writing support (editing, fact-checking, proofreading, literature search, gap analysis, reference management, slide development, etc.)

We are comfortable with starting from scratch or using your in-house templates. And we have experience in multiple therapeutic areas.