Pharmaceutical and life sciences law

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The regulations governing human medicines, veterinary medicinal products and medical devices are largely harmonised at the European level.

 

At the same time the volume of regulation is steadily increasing with regards to safety, quality requirements, also marketing and advertising rules. In order to avoid or reduce the risk of sanctions and corporate liability, companies in the pharmaceutical industry have to ensure compliance with these standards through continuous expert review and corporate rules as well as procedures.

 

Comprehensive international and interdisciplinary consulting with legal representation for companies in the pharmaceutical industry 

Our legal experts comprehensively advise and represent companies in the pharmaceutical industry across national borders on all questions which may arise during product development and the manufacture, distribution and marketing of the product.

 

The range of consulting services includes, for example, regulatory questions relating to the product, including recommendations for the creation of compliance organisation in the pharmaceutical sector, representation against local and international authorities and institutions, defence in criminal proceedings and assistance with non-compliance procedures, competition law and industrial property protection.

 

Our legal consulting integrates our global experience, special knowledge of international law and expertise regarding the comparison of legal systems to enable us to develop innovative solution concepts.

 

Wide range of consulting services for pharmaceutical law 

Our clients in the pharmaceutical sector have to observe numerous aspects and legal requirements starting with the initial product idea including the development, manufacture and marketing of the product. Rödl & Partner offers the following comprehensive expertise:

  • Product classification and legal differentiation
  • Marketability testing for EU member states and other countries
  • Approval, registration and notification procedures
  • Consulting for product safety and liability including assessment of liability risks
  • Support for crisis management and communication (recalls, product warnings)
  • Consulting for quality management (e.g. good manufacturing practice, good distribution practice)
  • Review and improvement of the product marking and product information texts
  • Consulting for product advertising, in particular regarding pharmaceutical advertising
  • Competition and antitrust law in the pharmaceutical sector (e.g. consulting for the prohibition of unfair commercial practices and restrictive agreements including price fixing and parallel trade)
  • Contract design (e.g. non-disclosure agreements, research and development contracts, contract manufacturing agreements, quality assurance agreements, distribution agreements including distribution contracts and licenses)
  • Intellectual property (e.g. defence and enforcement of intellectual property rights such as trademarks and patents)
  • Consulting in connection with legal questions concerning customs and foreign trade
  • Regulatory offence procedures and assistance with proceedings in courts
  • Representation against local and international authorities.

Contact

Contact Person Picture

Eglė Pinaitė

Senior Lawyer

Associate Partner

+370 5 212 35 90

Send inquiry

Contact Person Picture

Dr. Jelena Lysovienė

Senior Consultant, Life Science Expert

+370 5 212 35 90

Send inquiry

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