Clinical and Regulatory Documents Preparation

Clinical and Regulatory Medical Writing

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.