Specializing in Briefing Documents, Annual Reports, and More

On average, our writers have 10 to 15 years of experience in medical writing.

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
  • 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 (device)