Offer Summary

Services

Methodology and Ethics

Specific Expertise

About me

Specific Expertise

  • Evaluation, assessment and expert advice on the preparation of the CMC and Clinical parts
  • Writing of chemical-pharmaceutical dossiers, quality overall summaries (QOS) and clinical overview for medicinal products (CTD format)
  • Preparation, review and editing of CTD files, Marketing Authorisation Applications
  • Lifecycle management of MAA (Writing, preparation/compilation, submission and follow-up of variations and renewal)
  • Liaise with European Health Authorities (EMA)
  • Liaising directly with the Belgium and Luxembourg regulatory agencies
  • Preparation and review of Drug Master File and Eur. Ph. Certificate of Suitability file
  • National Pharmacovigilance services
  • Review and regulatory sign-off of advertising and promotional materials
  • Acting as QP