Our writing skills and industry expertise ensure Acadustri can provide the support and guidance needed to prepare the following clinical and regulatory documents:
- Clinical Study Reports for phase I-IV trials to ICH guidelines
- Investigator’s Brochures
- Study Protocols & Protocol Amendments
- INDs & NDAs in CTD formats
- ‘Response to Questions’ Documents
- Responses to EMA Day 120 & Day 180 Questions
- Briefing Books for EMA & FDA Scientific Advice
- Applications for Orphan Drug Designation
- Investigational Medicinal Product Dossiers
- Literature searches/reviews
Contact us to discuss your project needs.