Healthcare and Life Sciences
#wearehealthcareandlifesciences
Health Care and Life Sciences
We advise and support companies with deep sector knowledge in all areas of the healthcare and life sciences sector – pharmaceuticals, biotechnology, medical devices (including IVD’s), digital health, health institutions, medical professionals, AI.
We provide legal services to leading large companies, small and medium business as well as start-ups, be it producers, wholesalers, retailers, transportation and storage companies, health institutions, laboratories.
Our aim is to enable our clients to achieve their goals, by providing practical advice in line with legal requirements on complex regulatory, competition, compliance requirements.
We offer interdisciplinary support for your M&A transactions, commercial/ IP and patent litigation (in close cooperation with patent attorney), data protection and cyber security advice, product liability, administrative disputes with regulators and fines.
Your contact
Iliyana Sirakova
Partner | Attorney at Law | Head of Healthcare & Life Sciences
Our expertise in Healthcare and Life Sciences
We advise producers, wholesalers, distributors, transportation companies on product development and positioning, marketability of medicinal products and medical devices. We support in all matters relating to marketing authorization, conformity assessment procedures, certification.
We provide advice on labeling and advertising of medicinal products and medical devices, and represent you before competitors, authorities, and courts.
We support with compliance advice, communication, and crisis management (including recalls/ withdrawals).
Food is amongst the most regulated sectors. There are general food regulations and specific norms on e.g., novel food, additives, supplements, food for special consumer groups (incl. dietary and children), GMO, wine and spirits.
We advise producers and distributors of cosmetics every step of the way: classification, formulation, product positioning, labeling, and advertising, quality and risk management.
Requirements for natural cosmetics and demarcation issues.
Das Chemikalienrecht (einschließlich Detergenzien und Biozide) ist sowohl auf europäischer als auch auf nationaler Ebene geregelt (z.B. CLP-Verordnung, REACH, Chemikaliengesetz). Es umfasst Vorschriften für den Marktzugang (Registrierung, Anmeldung, Lizenzen), Kennzeichnungsvorschriften, Vorgaben für Produktsicherheitsblätter, Vertriebs- und Arbeitsplatzbeschränkungen – insbesondere für gefährliche und giftige Stoffe.
Tabakerzeugnisse sind auf europäischer Ebene mittels Richtlinie geregelt. Die Umsetzung in den einzelnen Mitgliedstaaten ist nicht komplett einheitlich, die Judikatur und die gelebte Praxis auch nicht. Die Vorschriften erfassen Vorgaben für die Anmeldung (/-fristen), Zusammensetzung, Kennzeichnung, Werbung und den Vertrieb der erfassten Produkte (u.a. Tabak, e-Zigaretten mit und ohne Nikotin, pflanzliche Raucherzeugnisse). Wir unterstützen unsere Mandanten ihre Produkte rechtssicher auf dem österreichischen Markt einzuführen und zu vermarken.
Wir beraten Sie bei jedem Schritt, gemeinsam mit unseren Steuerrechtsexperten auch in Bezug auf die Abgaben und Steuern.
Our experts in Healthcare and Life Sciences
Healthcare and Life Sciences News
AI in companies – also a legal challenge
“Most users give very little thought to when they enter which data into which AI systems.”
Home DNA tests under the microscope
Christian Kern, lawyer in the Data Protection | Cybersecurity & IP/IT | Media Law team, explains the data protection concerns regarding home DNA tests.
The limits of data retention
A recent ECJ verdict confirms that states may not circumvent the ban on data retention by obliging private providers to collect data from the state by law.