Franziska Huber

Life Sciences Regulatory

Dr Franziska Huber is an Associate in Fieldfisher´s Munich office and advises on all regulatory issues in the Life Science sector.

Our clients include national and international companies. Her particular focus is on advising pharmaceutical companies and manufacturers of medical devices on regulatory matters. She also provides support in the negotiation and drafting of various types of contracts in the Life Sciences sector.

In addition, as part of the Life Science Regulatory Practice Group at Fieldfisher, she advises on market access, particularly with regard to reimbursement and pricing of medicinal products and medical devices in the inpatient and outpatient service sector of the SHI, including method assessment procedures before the G-BA as well as negotiations with statutory health insurance funds and the SHI-SV.

The regulatory advisory practice includes in particular the placing on the market of medicinal products and medical devices (conformity assessment procedures, marketing authorisation, distribution, GDP, contracts between actors in the supply chain), wholesale authorisations, compassionate use and single importation, clinical trials and good manufacturing practice.

She studied in Augsburg and worked there as the Managing Director of the Institute for Bio-, Health- and Medical Law at the University of Augsburg during her doctorate on a Medical Law topic.