Medical Writing

SEQ 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 de novo scoping and writing, re-writing, and technical aspects such as formatting and compilation.

This SEQ service is 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 – whether for NCEs or approved products

  • 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)

  • Pharmacovigilance Master Files

  • Clinical expert statements

  • Reclassification applications (POM to P, or P to GSL)

For more information please contact us at: enquiries@nerin.co.im