Medical Writing


Medical Writing


  • Diverse Therapeutic Expertise:
    • Our medical writing services cover a broad spectrum of therapeutic areas.
    • Our experienced medical writers hold PhDs in life sciences and have over a decade of experience.
  • Integration with Clinical Development Teams:
    • Our medical writing service seamlessly integrates with multidisciplinary clinical development teams.
  • Experienced Scientific Writers:
    • Our team of scientifically oriented writers possesses significant experience in crafting clinical documents.
  • Regulatory Document Excellence:
    • We excel in crafting regulatory documents that support submissions to regulatory agencies for drugs, devices, and diagnostics.
  • Regulatory Environment Proficiency:
    • We understand the intricacies of writing within highly regulated environments and are well-versed in the requirements of regulatory agencies.


Medical Writing for Clinical Trials & Regulatory Submissions

Clinical Trial and Program Documentation:

  • Protocol-related Documentation:
    • Protocol synopsis, protocols, and amendments
    • Informed consent forms
    • Clinical study reports (CSRs)
    • Safety narratives
    • Clinical development plans
    • Investigator brochure and patient information leaflets
    • Annual reports
    • Periodic safety update reports (PSURs)
    • Development safety update reports (DSURs)
    • Periodic benefit-risk evaluation reports (PBRERs)

Regulatory Submission Documents:

  • Marketing Applications in eCTD Format:
    • IND (Investigational New Drug)
    • CTA (Clinical Trial Application)
    • NDA/sNDA (New Drug Application/supplemental NDA)
    • MAA (Marketing Authorization Application)
    • NDS (New Drug Submission)
    • jNDA (Japanese New Drug Application)
  • Clinical & Non-Clinical Summaries (Module 2)
  • Integrated Summaries of Efficacy and Safety (Module 5)
  • Responses to Agency Reviewers
  • Regulatory Briefing Documents for Agency Meetings, including:
    • Pre-IND
    • End of Phase 1
    • End of Phase 2/3
    • Pre-NDA
    • Advisory Committee Meetings
  • Orphan Drug Designation Applications
  • Risk Management Plans

eCTD services

  • Create and edit eCTD documents according to ICH and national regulatory authority guidelines.
  • Manage documents and eCTD sequence lifecycles on a dedicated document management system.
  • Create and publish eCTD sequences on a dedicated eCTD compilation system.
  • Validate eCTD sequences using specialized validation tools.
  • Submit eCTD sequences to regulatory agencies.


Contact Form 

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Phone: +1 (650) 460-7431


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Visit us: 530 Lytton Avenue, 2nd Floor, Palo Alto, CA 94301

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