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Caroline Schmalenbach
Associate Global Regulatory
Languages
English, German
She provides legal advice, in particular, on the drafting and negotiation of commercial agreements, especially in the area of research, development, manufacturing and supply. In addition, she regularly assists with the review and negotiation of clinical trial agreements. She also helps clients to identify compliance risks in collaborations with health care professionals. Her extensive expertise in providing legal advice on the marketing and advertising of medicinal products, particularly prior to market launch, and medical devices makes her a valued point of contact for a large number of clients.
During her legal training she gained experience in several international major commercial law firms.
Assisting AbbVie GmbH in filing a constitutional complaint against the price and reimbursement restrictions of the German Act for the Financial Stabilisation of Statutory Health Insurance.
Advising Fresenius Kabi AG in connection with the divestment of a pharmaceutical production facility in Norway.
Comprehensive advice to a US biotech company regarding communication in a scientific context about a drug that has not (yet) been approved in the European market (pre-approval marketing).
Drafting of a licence, manufacturing and supply agreement for an innovative pharmaceutical product for a global life science company.