Medical Writing for Clinical Trials & Regulatory Submissions
Veristat provides medical writing support for the full life-cycle of a product’s development, beginning with early-stage development through marketing application and post approval. We offer rapid turnaround to meet tight timelines, and flexible, efficient processes for any project large or small. Using in-house or sponsor-supplied document templates, we apply best practices for content, format, and style to meet global technical and regulatory requirements. Our expert medical writing team supports the development of the following types of documentation:
Clinical Trial & Program 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 (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)
- 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 and Advisory Committee
- Orphan Drug Designation Applications
- Risk Management Plans
