Former GC of international green biotech and white biotech companies and of the world leader in genomics, Kathleen founded a boutique consultancy for legal, regulatory and compliance for biotech companies www.lifesciencelegaldesign.com
The main focus is white and green biotech, medical devices, medtech, agri- and food law.
Experiences include: breeding and variety legislation and regulation, legal and compliance support at CPVO (Community Plant Varity Office, legal and compliance support for EMA, FDA, USDA, legal and strategic support in files for bringing new medication to market, reimbursement of medication in EU countries (e.g. neue Untersuchungs- und Behandlungsmethoden (NUB) in Germany, negotiations with CRO’s and investigative sites for the setup of clinical trials, negotiations with insurance companies on liability, legal support for horizon 2020 dossiers.
Kathleen consults international (medical) cannabis companies for the above mentioned subjects.