Regulatory writing services include development of various regulatory documents, including but not limited to:
• Clinical Trial Documents for all clinical trial phases and study designs
- Study synopses development
- Study protocols and amendments
- Investigator’s brochures and annual updates
- Informed consent documents
- Case report forms
- Patient/study-related materials like advertisements, patient cards, patient diaries, etc.
- Prescribing information
• Clinical Study reports (ICH-E3 compliant)
• Marketing authorization dossiers for drug, device and biologics for all regulatory authorities including EMA, FDA, CDSCO, and emerging markets.
- Clinical sections of CTD submissions (Modules 2.5, 2.7 and 5.0) and expert statements
- Non-clinical sections of CTD submission (Modules 2.4, 2.6, and 4.0) and expert statements
- Update and gap analysis of various CTD components
• Event/Safety narratives
• Response to Regulatory Authorities; Regulatory meeting briefing documents and related write-ups
• DSMB updates, integrated safety summaries, risk management plans (EU-RMP), aggregate reports (DSURs, PSURs – compliant to ICH E2C and E2F guidance) and other pharmacovigilance documents
• Statistical analysis plan in conjunction with biostatisticians
• Feasibility survey reports, disease demographics
• Standalone QC and review of documents