Claudia has been with NDA since 2014 her broad regulatory experience successfully supports clients throughout the development and licensing of their medicines, including post-approval and launch.
Claudia leads and contributes to a multitude of key meetings with regulatory agencies and successful milestone submissions in Europe and the US.
Her ability to think-out-of-the-box is a great asset to our clients, especially for the optimization of their regulatory strategies.
Claudia is the lead for our strategic initiative to support clients through Project Orbis. Project Orbis is an initiative of the FDA providing a framework for concurrent submission and review of innovative oncology products among international partners from Australia, Brazil, Canada, Singapore, Switzerland, UK and USA.
Key Areas Of Expertise
- Regulatory support / strategic input to regulatory milestone filings:
US New Drug Applications (NDA), EU Marketing Authorisation Applications (MAA), EU Clinical Trial and US Investigational New Drug Applications (CTA and IND)
- Post-approval activities, including but not limited to line extensions, renewals, variations, referrals, MAH transfers, ODD annual reports
- Profound knowledge in decentralised, centralised and European national procedures, new chemical entities as well as generics and hybrids
- Scientific writing of Module 3 documents and quality expert reporting (Module 2.3) incl. US DMF filings
- Regulatory expertise spans over small molecules, biotechnological, blood products, vaccines and drug-device-combinations (e. g. device kits, prefilled syringes, pumps etc.), drug-device borderline products
- Support of Scientific Advice meetings in the EU and US
- Specialised in regulatory strategies for product registration in Europe
Claudia started in the pharmaceutical industry in 2006 as a Junior Clinical Research Associate (Clinical Research/Pharmacovigilance) at IDEA AG, Munich. Then moved on to Cephalon and worked in Regulatory Affairs in the indications CNS, pain and oncology with European regulatory responsibilities in addition to local duties for Germany, Austria and Switzerland. From 2011 to early 2014 at Zentiva Inhalationsprodukte GmbH, Munich (Sanofi group) where she worked in the development of generic inhalation with focus on CMC documentation.
Claudia is a registered Pharmacist and Master Drug Regulatory Affairs (M.D.R.A.).