Mercia Lucouw works as a regulatory affairs associate at Qdossier, a Celegence company.
She provides regulatory support to a variety of pharmaceutical companies.
Mercia holds a bachelor degree in pharmacy (B.Pharm) from the North West University,
South Africa. For ten years she worked as a pharmacist in hospital and has routinely been
involved in international clinical trials. She is passionate to promote healthcare and recently
started her career in regulatory affairs. After joining Qdossier in 2021, she has been involved
several regulatory activities covering a variety of products.
Mercia’s areas of expertise are preparation/creation and dispatch of different types of
electronic submission formats (e.g. US FDA, CA, EMA, CH), lean/structured authoring. She
is also part of the development team for Dosscriber™ (MS word eCTD document templates).
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.