Medical Writing

Medical Writing

OUR MEDICAL WRITING TEAM’S EXPERTISE

• 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.

HOW WE HELP YOU

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 US FOR FREE CONSULTING

Contact Form 

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