Regulatory Writing

Content creation is quided by commercial, eCTD-compliant MS Word templates and Style Guides, following FDA 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:

• FDA 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