Biography
Katrin Helle is an expert in public commercial law, with a particular focus on the healthcare and life sciences industry as well as technology regulation.
Clients who have benefited from her longstanding and deep regulatory experience, in particular in the pharmaceutical, medical device, hospital, nursing homes, and healthcare services business, include major domestic and international companies as well as international private equity firms and strategic investors. Katrin helps clients to navigate complex national and cross-border projects and transactions with her knowledge on the EU and German legal framework, ensuring that their business operations are fully compliant with all applicable regulations.
Katrin's clients value her comprehensive expertise in life sciences and healthcare regulation. She is a highly recommended lawyer for Pharmaceutical and Medical Device Law in the legal directory JUVE 2023/2024 and named as Best Lawyer Germany in Biotechnology Law, Health Law and Pharmaceutical Law in the Handelsblatt 2025.
Experience
Pharma, Biotechnology & Pharmacies
Summit Partners
Advised the leading growth-focused investment firm on its investment in Dreampath Diagnostics.
Goldman Sachs
Advised Goldman Sachs on its majority investment in Synthon, a global leader in complex generic drug development and manufacturing
Global Biotechnology Company
Representation in court proceedings throughout Germany in relation to product liability claims
Admaius
Advised the Africa-focused private equity firm on their subscription for a stake in Minapharm, a leading biopharmaceutical company in Egypt with subsidiaries in Germany
Care Equity Capital / Momentum Biotechnologies
Advised Momentum Biotechnologies on the acquisition of OmicScouts, a CRO and established leader in the field of mass spectrometry-based proteomics
Neopharmed Gentili
Advised the Italian pharmaceutical company on the acquisition of the European business of ORLADEYO® (berotralstat) from BioCryst Pharmaceuticals
Zur Rose Group AG
Advised Swiss Zur Rose Group on its CHF 252 million IPO on the SIX Swiss Exchange
European Life Sciences Company
Advised a large life sciences company, active as pharmaceutical wholesaler and with pharmacies, on the acquisition of a major pan-European online health company, operating (online) pharmacies
Medical Devices
Adelis
Advised Adelis on the sale of its majority stake in life science research reagents specialist distributor Europa Biosite to EQT Healthcare Growth.
Battery Ventures
Advised on the acquisition of steute Technologies GmbH & Co. KG, a developer and manufacturer products for medical and industrial applications.
Nordic Capital
Advised Nordic Capital on its acquisition of Sunrise Medical and on the acquisition of imes-icore Holding GmbH, a leading provider of CNC-CAD/CAM systems for the dental market
Zimmer Holdings
Advised the leading maker of orthopaedic implants on its US$ 13,35 billion acquisition of Biomet Inc., one of the world's leading medical device manufacturers
HealthTech
Armira Growth
Advised the leading investment company on the investment in nyra Health, a HealthTech company that markets an AI-based digital neurotherapy for personalized care
Leading international pharmaceutical company
Advised on a consortium agreement for an innovative, AI open-source tool "GUIDE-AI" subsidized by the Innovative Health Initiative, a public-private partnership between the European Union and the life sciences industry
XO Life GmbH
Advised XO Life on life sciences regulatory issues including AI compliance in connection with its briteTM platform, a one-stop solution for users in the context of a medical treatment or medication
University Hospital Tübingen
Advised the University Hospital Tübingen on the establishment of the German Network for Personalized Medicine with more than 20 university hospitals*
Telemedicine Providers (Medgate Deutschland GmbH, Meliva Deutschland GmbH and others)
Advised on telemedicine issues under German medical professional and social security law and law on advertising of medicine*
Digital Health Applications Providers (Vivira Health Lab GmbH, Sympatient GmbH, HiDoc Technologies GmbH)
Advised provider on regulatory compliance and representation in price negotiations*
Healthcare Regulatory
IK Investment Partners
Advised IK Investment Partners on its acquisition of ZytoService Deutschland GmbH, a leading compounder of pharmaceuticals for patient-individualised infusions
Nordic Capital
Advised Nordic Capital on its acquisition of Prospitalia, of Ober Scharrer, of Alloheim, and its acquisition of GHD GesundHeits GmbH Deutschland
* Matters prior to joining White & Case
Best Lawyer Germany in Biotechnology Law, Health Law and Pharmaceutical Law, Handelsblatt 2025
Highly Recommended Lawyer
Pharmaceutical and Medical Device Law, JUVE 2022/2023
"AI in high-performance medicine against cancer—the medical care of the future", Panel discussion, November 2025
"Decoding the EU AI Act: Regulation, Innovation, and Economic Impact", Roundtable, October 2025
"Key changes in EU Medical Devices Regulations and how they impact MedTech businesses", Webinar, July 2020
"Future Scoping New Market Developments and the Impact on the Medical Devices Market," Chair of panel discussions, MedTech Summit, Brussels, June 2019
"From Principles to Proof: How 2025 Made AI Governance Real in Health Care", AIPO Journal Commentary – January 2026
„Intelligent medical devices in the triangle of responsibility and liability between the Medical Devices Regulation, AI Regulation, and Product Liability Directive (Intelligente Medizinprodukte im Verantwortungs- und Haftungsdreieck zwischen Medizinprodukteverordnung, KI-Verordnung und Produkthaftungsrichtlinie)", MedR 2025, Pages 677-681
"Intelligent medical devices: Is the current legal framework still up to date? (Intelligente Medizinprodukte: Ist der geltende Rechtsrahmen noch aktuell?)", MedR 2020, Pages 993-1000
"Legal framework applicable to mobile health (Rechtliche Rahmenbedingungen für mobileHealth)", MedR 2015, Pages 485-491
"Legal limits to cooperation between the medical device industry and health care institutions (Rechtliche Grenzen der Kooperationen zwischen Medizinprodukteindustrie und medizinischen Einrichtungen)", MedR 2014, Pages 152-157
Co-author, "Constitutional limits of reviews by courts of processing fee clauses in consumer loan agreements (Verfassungsrechtliche Grenzen der gerichtlichen Kontrolle von Klauseln über Bearbeitungsentgelte in Verbraucherkreditverträgen)", WM 2011, Pages 1877-1924 (with Henning Berger)
"Constitutional aspects of hospital-financing based on diagnosis related groups (Verfassungsrechtliche Aspekte des Fallpauschalensystems im Krankenhauswesen (DRG-Vergütungssystem))", Dissertation, Baden-Baden, 2008
