Regulatory and Clinical Writing

Medical Writing is an integral part of clinical research and Guires has extensive experience and expertise in the non-clinical and clinical and regulatory aspects in compliance with national and international regulations and guidelines. Our experienced medical research support team offers a fully compliant and high-quality medical writing services support to both global and also European Union (EU) marketing authorization holders.
Our regulatory and clinical writing includes

• Study Protocols
• Investigator Brochures
• Investigational Medicinal Product Dossiers (IMPD)
• Clinical and non-clinical sections of the common Technical Document (CTD) – Chemistry including summaries and overviews for US and EU Regulatory Authorities
• integrated Summaries of efficacy and safety
• Manufacturing and Controls (CMC, non-clinical and clinical documents
• Clinical Expert statements
• Pharmacovigilance Master Files
• Risk Management Plans (RMPs)
• Medical Review of PSURS
• Labeling documents- Summary of Product Characteristics (SmPC), patient information Leaflets (PIL/PL), Medication guides, US prescribing Information (USPI)
• Clinical evaluation Reports (CER) for medical devices