Multinational Companies

Because many of our clients operate in foreign markets, our team has become familiar with the cultures, laws and regulations of those foreign jurisdictions. We are part of a network of trusted foreign attorneys and advisors which enables our firm to advise on establishing and adequately maintaining manufacturing and selling goods and services worldwide.

Several members of our firm have experience with international patent, regulatory and transactions in more than thirty countries. We have assisted clients having headquarters in Europe, Canada, Mexico, Asia, the Caribbean, and other parts of the world. Utilizing our network of foreign associates, we have helped guide our clients in establishing foreign entities, manufacturing facilities, and international supply and distribution channels. In addition, we have experience drafting and negotiating international technology license agreements between our clients and foreign suppliers and distributors. For example, we recently helped a client develop an AI-enabled SaaS platform for sales of regulated products in Canada, Mexico, and Brazil, among other countries.

In addition to helping US companies operate in foreign markets, we also support foreign companies seeking to establish US operations, including US research, development, manufacturing and distribution facilities.

In particular, we have assisted clients with regulatory compliance and mitigating regulatory risk in many jurisdictions. We have experience helping our clients navigate complex international regulatory issues around the world, including drug approvals, medical device clearances, and clinical trials in:

• Europe (EMA),
• China (NMDA), 
• Health Canada,
• Australia (TGA),
• Japan (PMDA), and
• India (DCGI).

In addition, we have helped our clients navigate import-export and privacy laws and regulations including:

• US Export Administration Regulations (EAR),
• US International Traffic in Arms Regulations (ITAR),
• US Foreign Corrupt Practices Act (FCPA),
• UK Bribery Act,
• EU General Data Protection Regulation (GDPR), and
• US Health Insurance Portability and Accountability Act (HIPAA).

With respect to entity creation and cross-border tax issues, we work with US tax and securities co-counsel to help evaluate the tax implications of creating foreign subsidiaries, or US subsidiaries from foreign jurisdictions. For example, members of our firm have assisted in the formation of companies and subsidiaries in the Cayman Islands, Ireland, Mexico and Canada. Our members have also handled due diligence in international mergers and acquisitions for life sciences and healthcare companies having operations throughout the world.

Finally, we are best known for our international intellectual property and pharmaceutical lifecycle management experience. For information on these and other legal, regulatory, and business matters, please contact us.