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"Latham has one of the best practices in healthcare: it has extensive knowledge of the regulations and gets involved in most of the healthcare reforms."
Chambers Europe 2012

European Union Life Sciences Regulatory

Latham & Watkins has one of the most comprehensive life sciences practices in the European Union.

With offices located in leading European business centers in the United Kingdom, Spain, France, Belgium, Italy, Germany and Russia, Latham can be matched by few firms in terms of depth and breadth of geographic coverage, and regulatory expertise in Europe.

Latham Advises On Development and Marketing of New Technologies

The development and marketing of medical technologies are now global undertakings. Latham has structured its regulatory and transactional practices to meet the needs of clients seeking to establish a global footprint for medical technologies in the growing markets of the United States and Asia.

The firm's substantial European presence, coupled with its industry expertise, enables its lawyers to provide clients with sophisticated, multi-disciplinary advice on the unique regulatory, intellectual property and economic considerations facing US and European companies in conducting cross-border clinical trials, commercializing life sciences technologies in Europe and exporting those technologies to the United States.

Latham's European and US lawyers advise life sciences clients throughout the full life-cycle of their products. The firm assists clients in the development and implementation of:

  • Effective and efficient clinical and pre-clinical testing programs
  • Market client products
  • Patent and regulatory exclusivity
  • Securing reimbursements
  • Submission and approval of pre-market applications
  • Strategy-development

Following product launch, Latham assists companies in post-market compliance with the on-going requirements relating to the manufacture, marketing, distribution and safety of their products. The firm also provides advice and counseling in:

Comprehensive Expertise

Latham's lawyers work with their clients to:

  • Counsel clients on post-market compliance with EU and US requirements, including recalls and other safety-related actions, and governmental investigations and enforcement
  • Develop and implement global clinical trial strategies designed to support European and US approvals, and facilitate compliance with applicable international laws and regulations including:
    • Data protection laws and directives
    • Data privacy laws
    • EU Clinical Trial Directives
    • International Conference on Harmonization (ICH) standards
    • Institutional Review Board and Ethics Committee approvals
    • Patient informed consent requirements
    • US Food and Drug Administration (FDA) Good Clinical Practices
  • Develop pre-market approval strategies for pharmaceutical, device and biosimilars in the European Union and its member states, and prepare pre-market submissions, including conformity assessments and applications for marketing authorizations
  • Draft and negotiate agreements for key commercial transactions involving EU entities, such as:
    • Collaboration
    • Co-promotion agreements
    • Licensing agreements
    • Marketing, supply and distribution agreements
    • Strategic partnership agreements
  • Manufacturing compliance counsel, including compliance with ISO standards and other good manufacturing practice requirements through third-party audits and development of standard operating procedures
  • Research and development agreements
  • Strategic counsel on market exclusivity strategies, as well as product labeling, advertising and promotional compliance
  • Strategic counsel on pricing and reimbursement of medical technologies in the European Union and the United States
  • Strategic counsel on complex intellectual property, commercial and product liability disputes in the European Union and the United States
 
 
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