Scientific and Regulatory Writing

Our experienced writers generate scientific and regulatory documents in an accurate, thorough and flexible manner.

With their scientific background, they are conversant in the analysis, interpretation and presentation of data originating from different areas of drug development (preclinical, clinical, CM&C).

Our team of regulatory writers produce high quality submission documents for pharmaceuticals and medical devices. We have extensive experience in writing regulatory dossiers. We therefore know exactly what level of detail needs to be included in a dossier.

Typical writing services we provide are:

General services we provide:

  • Literature searches
  • Scientific advice packages
  • Pediatric investigation plans
  • Marketing Authorisation Applications (MAA)/ New Drug Applications (NDA)
  • Investigational Medicinal Product Dossiers (IMPD)/ Investigational New Drugs (IND)
  • Standard Operating Procedures (SOPs), Working instructions
  • Responses to questions
  • Deficiency letter responses
  • Post-approval variations

 

Pre-clinical

  • Safety study reports
  • Safety risk assessments
  • Permitted Daily Exposure Reports
  • Genotoxicity assessments
  • CTD modules 2.4 and 4

Clinical

  • Clinical study protocols
  • Clinical study reports
  • Investigator Brochures
  • CTD Modules 2.5 and 5

CM&C and Quality

  • Process validation reports
  • Stability reports
  • Quality risk assessments
  • Cleaning validation reports
  • ICH Q3D risk assessments
  • CTD Modules 2.3 and 3

Pre-clinical
Clinical
CM&C