- 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
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