Daniela has been with NDA since 2011. She supports our clients during the development of their medicinal products with strategic and operational advice for small and large molecules, throughout early to late development, marketing authorisation and following on with launch support and life cycle management.
Key Areas Of Expertise
- Regulatory strategic advice and project management (CP, MRP, DCP, US NDA/BLA)
- Preparation of Regulatory Roadmaps including identification of opportunities for accelerated approval
- Preparation / Coordination of Scientific Advice and Pre-Submission Meetings with the EMA and National European Health Authorities
- Preparation / Coordination of PIP applications with the EMA
- Regulatory project management, preparation and submission of new marketing authorization applications (CP, MRP, DCP, national) including Linguistic Review Procedure
- Maintenance of marketing authorization (CP, MRP, DCP, national)
- Establishment of product information
- Launch support and review of Marketing Material
- Scientific Information Officer under the German Drug Law
Daniela was Head of Regulatory/Medical Department at Sandoz Pharmaceuticals GmbH. As part of that role she was also the local responsible person for Pharmacovigilance (Stufenplanbeauftragte) and Scientific Information Officer (Informationsbeauftragte) under the German Drug Law.
She is a pharmacist by training and has 20 years of experience in Regulatory Affairs for both new chemical entities and known active substances.