Regulatory Publishing Specialist & Trainer
Pharma to Market Pty Ltd
Daria is a regulatory publishing expert and certified trainer covering global electronic submissions. She has extensive knowledge of international authorities AU, NZ, EU, US.
- Extensive knowledge of eCTD, NeeS formats and lifecycle management, document authoring & management practices, Lorenz docuBridge software; submission to international authorities including AU, NZ, EU, US, Canada, Thailand, GCC, Switzerland, UK.
- Expert use & troubleshooting of publishing software including Lorenz eSolutions portfolio, Debenu Aerialist, Adobe Acrobat range, and Toolbox.
- Project management of outsourced electronic and hard copy regulatory submissions, involving authority, client and third-party related aspects.