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Elisabeth Kohoutek advises companies in the Life Sciences sectors. Elisabeth guides clients in complex regulatory matters and represents them in litigation and business transactions.

Elisabeth is passionate about Digital Health and an expert on privacy, AI, and health laws.

As a member of our FDA & Life Sciences practice, Elisabeth counsels companies in the drug, device, food, cosmetics, chemical and related industries. Elisabeth focuses on advertising, labeling, classification, composition, regulatory compliance, ESG and privacy matters under both European Union (EU) and German laws. With 8+ years of practice, Elisabeth has broad experience in solving issues in highly regulated sectors, both out-of-court and in court proceedings and transactions.

Determined to bring forward the health system and to improve patient treatment options, Elisabeth is an active part of the Digital Health movement.

Elisabeth studied law at the Ruprecht-Karls-University in Heidelberg. 

She speaks German, English, Czech and Spanish.

Full Bio

Credentials

State Exam, Ruprecht-Karls-Universität Heidelberg

Frankfurt

Frankfurt, Germany (Admitted 3/8/2012; Reg. # 148821)

Czech

English

German

Spanish

Recommended Lawyer for Healthcare and Life Sciences


Legal 500 Deutschland, 2021

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Recognition

Recommended Lawyer for Healthcare and Life Sciences


Legal 500 Deutschland, 2021

Matters

Counseling a world-wide leading manufacturer of medicinal products in all aspects of parallel imports in the EU

Counseling a world-wide market leading manufacturer of medical devices in regulatory and advertising law

Counseling internationally acting pharmaceutical companies in the area of distinction between food and pharmaceutical products

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Matters

Counseling a world-wide leading manufacturer of medicinal products in all aspects of parallel imports in the EU

Counseling a world-wide market leading manufacturer of medical devices in regulatory and advertising law

Counseling internationally acting pharmaceutical companies in the area of distinction between food and pharmaceutical products

Representing manufacturers of medicinal products and medical devices in cases concerning the market authorization and the “CE-mark” versus authorities and Notified Bodies

Representing U.S. companies in processing personal data gathered in the European Union

Insights

Newsletter

June 1, 2021
ESG Spezial - June 2021

Article · Source: Practical Law

May 27, 2021
Artificial intelligence: the dawn of a new legal era

View all

Matters

Counseling a world-wide leading manufacturer of medicinal products in all aspects of parallel imports in the EU

Counseling a world-wide market leading manufacturer of medical devices in regulatory and advertising law

Counseling internationally acting pharmaceutical companies in the area of distinction between food and pharmaceutical products

See more
Icon close

Close

Matters

Counseling a world-wide leading manufacturer of medicinal products in all aspects of parallel imports in the EU

Counseling a world-wide market leading manufacturer of medical devices in regulatory and advertising law

Counseling internationally acting pharmaceutical companies in the area of distinction between food and pharmaceutical products

Representing manufacturers of medicinal products and medical devices in cases concerning the market authorization and the “CE-mark” versus authorities and Notified Bodies

Representing U.S. companies in processing personal data gathered in the European Union

Insights

Newsletter

June 1, 2021
ESG Spezial - June 2021

Article · Source: Practical Law

May 27, 2021
Artificial intelligence: the dawn of a new legal era

View all

Credentials

State Exam, Ruprecht-Karls-Universität Heidelberg

Frankfurt

Frankfurt, Germany (Admitted 3/8/2012; Reg. # 148821)

Czech

English

German

Spanish

Recommended Lawyer for Healthcare and Life Sciences


Legal 500 Deutschland, 2021

Icon close

Close

Recognition

Recommended Lawyer for Healthcare and Life Sciences


Legal 500 Deutschland, 2021