Medical and regulatory writing
We offer regulatory and medical writing services throughout the lifecycle of your product, from preclinical development to marketing authorization and product maintenance phase. Our expert team provides you support in the preparation and review of documents for regulatory submissions and clinical trials.
- • Investigator´s Brochures
- • Investigational Medicinal Product Dossiers
- • Clinical study protocols and reports.
- • Clinical and non-clinical sections of the Common Technical Document (CTD)
• including summaries and overviews
- • Biowaiver justifications
- • Clinical and biological evaluations of medical devices
- • Manuscripts for publication
- • Environmental Risk Assessments Phase I (ERAs)
- • Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs)
- • › Pharmacovigilance