Regulatory Writing

Effective documentation and communication of scientific and clinical information are critical in product development.  They play a significant role in the success or failure of new compounds or devices. 

Our team of highly trained writers provide end to end solutions to your documentation needs including writing, editing and document management. With our strong knowledge in pharmacology and clinical development process, we are uniquely positioned to support your development efforts.  We can assist you in:

  • INDs/NDAs
  • Pre-IND meeting requests / packages
  • Common Technical Documents (CTDs)
  • Investigator's Brochure
  • Clinical Study Protocols
  • Clinical Study Reports (CSRs)
  • FDA Briefing Packages
  • Annual Reports
  • Integrated Summaries of Safety and Efficacy
  • Scientific Abstracts and Posters
  • Manuscripts