Regulatory Writing services
Content creation is quided by commercial, eCTD-compliant MS Word templates and Style Guides, following Health Authority and ICH Guidances. R&D Advisors can either manage your medical writing team and subject matter experts and/or actively participate in authoring and editing. Deliverables include:
- Health Authority Meeting materials
- Investigational New Drug (IND) submissions
- Investigational Device Exemptions (IDE) submissions
- New Drug Application (NDA) submissions
- Drug Master File (DMF) submissions
- Orphan Drug Designation requests
- Fast Track Designation requests
- Breakthrough Designation requests
- Clinical protocols, Informed Consent documents
- Investigator Brochures
- Clinical Study Reports
- Nonclinical Reports