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: firstname.lastname@example.org