Our team of dedicated, professional medical writers can provide a complete range of writing service. Our rigorous QA process ensures all contractual obligations and regulatory requirements are met. Global projects include certified translations when required.

Regulatory Submissions

  • IND, IDE, and CTA submissions
  • NDA, BLA, PMA, MAA, and PIP submissions
  • FDA and EMA briefing documents
  • Pre- and post-marketing annual and periodic safety reports (annual reports, DSURs, PSURs, PSRs, PBRERs)
  • Regulatory response

 

Clinical Development Programs

  • Manuscripts
  • Product monographs
  • White papers
  • Systematic literature reviews and meta-analyses

 

Clinical Studies

  • Identify appropriate study endpoints, design, patient populations, and methodology
  • Conduct feasibility studies to determine appropriate and timely approach to conducting clinical studies
  • Prepare clinical study documents, including study protocols, investigator’s brochures, study procedure manuals, and all other associated documents required