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Overview

  • Briefing documents
  • Protocols/amendments (Phase 1-4, Registries)
  • IBs
  • CSRs
  • INDs
  • NDAs
  • Narratives
  • Annual reports
  • Abstracts
  • aNDAs, sNDAs, 
  • NADAs, ANADAs, CNADAs (vetrinary/animal health)
  • Assessment aids (oncology)
  • BLA
  • Breakthrough designations
  • Clinical and Nonclinical summaries
  • Clinicaltrials.gov and other trial disclosures
  • CMC writing
  • Fast-track applications
  • Integrated summaries of safety and efficacy
  • Literature research
  • Manuscrips
  • Marketing applications in eCTD format (MAA, NDS, jNDA)
  • Orphan drug applications
  • Oharmacovigilance documents (risk management)
  • Development safety update reports (DSURs)
  • Periodic benefit-risk evaluation reports (PBRERs)
  • Periodic safety update reports (PSURs)
  • Plain language summaries
  • Posters
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