Medical Writing Services

On average, our writers have 10 to 15 years of experience in medical writing. We specialize in briefing documents, annual reports, and more. We work with both large and small companies, and can handle any scope of work from full project oversight to supplementing an in-house writing team when you need a little extra help. Take a look at some of the types of medical writing we can do for you. Or, if you're interested in joining our team, learn more about working at Synterex.

  • Briefing documents
  • Protocols/amendments (phase 1-4, registries)
  • IBs
  • CSRs
  • INDs
  • NDAs
  • Narratives
  • Annual reports
  • Abstracts
  • aNDAs, sNDAs
  • NADAs, ANADAs, CNADAs (veterinary/animal health)
  • Assessment aids (oncology)
  • BLA
  • Breakthrough designations
  • Clinical and nonclinical summaries (module 2)
  • Clinicaltrials.gov and other trial disclosures
  • CMC writing
  • Fast-track applications
  • Integrated summaries of safety and efficacy
  • Literature research
  • Manuscripts
  • Marketing applications in eCTD format (MAA, NDS, jNDA)
  • Nonclinical writing
  • Orphan drug applications
  • Pharmacovigilance documents (risk management)
  • Development safety update reports (DSURs)
  • Periodic benefit-risk evaluation reports (PBRERs)
  • Periodic safety update reports (PSURs)
  • Plain language summaries
  • Posters
  • Prescribing information
  • Regulatory briefing documents for agency meetings, including pre-IND, end of Phase 1, end of Phase 2/3, pre-NDA and advisory committee
  • Regulatory responses
  • Responses to agency reviewers
  • White papers
  • Clinical evidence reports (devices)

Looking for something else? See our other areas of expertise: