Specializing in Briefing Documents, Annual Reports, and More On average, our writers have 10 to 15 years of experience in medical writing. 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)