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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)


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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.