Scientific Writing
Assion has extensive experience and expertise in the quality, non-clinical and clinical regulatory aspects in compliance with national and international regulations and guidelines. We offer a full range of services including writing, re-writing and technical aspects such as formatting and compilation.
These services are carried out by our highly experienced qualified medical, pharmaceutical and scientific team. Our regulatory document writing services include:
- Investigational Medicinal Product Dossiers (IMPD)
- All components of the Common Technical Document (CTD)
- Chemistry Manufacturing and Controls (CMC), non-clinical and clinical documents
- Integrated summaries of efficacy and safety
- Medical review of Company Core Safety Information/ Company Core Data Sheets (CCSI/CCDS)
- Labelling documents – Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL/PL) and labels, US Prescribing Information (USPI) and Medication Guides
- Medical review of PSURs
- Risk management plans (RMPs)
Medical devices an Assion case study
Our client was undertaking the development of a medical device but unfortunately had no internal resources to manage the development and CE marking procedure to what was a tight schedule.