Regulatory Counseling

Regulatory Counseling

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You work in one of the most important, highly regulated businesses in the world—life sciences. The complexity grows constantly, with the introduction of new rules and regulations by local and national governments, regulatory authorities and other governing bodies. And the rules and regulations differ from region to region, country to country, state to state, province to province.

Dentons helps clients navigate the critical intersection of business, law and regulations. We use our in-depth knowledge and years of experience to align and tailor our advice to your very specific needs. Whether you are setting up a laboratory or manufacturing facility, performing clinical trials, obtaining product approvals, manufacturing and distributing products, obtaining marketing authorizations, obtaining coverage of your products, ensuring compliance, preparing and following up with audits, or implementing marketing and sales, we work with you to find practical, business-oriented solutions.

The world is shrinking. The pace of business is increasing. You don’t want to keep up—you want to lead. Dentons is here to help.

Experience

One of the largest brand pharmaceutical companies: Serving as US regulatory and compliance counsel and as anti-corruption, FCPA and product protection counsel on a global basis for one of the largest brand pharmaceutical companies on the globe.
Global healthcare leader: Advising in respect to structuring a promotion arrangement with one of the largest Russian distributors of its products, development of respective contracts between the parties; various antitrust aspects of promotion and distribution of its products in Russia, including development of its commercial policy; clinical trial agreements; product registration; combined marketing and promotion of complimentary products produced by the client and a third party; exclusion of a product from the Register of Vital and Essential Drugs; use of personal data by medical representatives; due diligence criteria for a selection of distributors; and inaccurate and misleading marketing and promotional materials of a competing product.
Major state university: Representing all of the teaching hospitals, other facilities and multiple faculty practice plans of a major state university with operations in multiple cities. Our task is to serve as principal outside transactional, regulatory and fraud and abuse counsel on all matters arising from the university's many healthcare providers.
Warner Chilcott: Assisting a US pharmaceutical group specializing in feminine health and skin care on all French aspects of the acquisition of the worldwide ethical pharmaceuticals division of Procter & Gamble. We also advised Warner Chilcott in Germany and Spain. Worldwide transaction value was estimated at $3.5 billion. Since then Warner Chilcott decided to reorganize substantially its European activities, and we have been advising on all corporate, commercial, regulatory and labor aspects of its 2011/2012 reorganization in France.

Insights

The evolving challenge of non-financial misconduct: do we have clarity?

November 16, 2023

United Kingdom: More than five years after first discussing non-financial misconduct as a regulatory priority, the UK Financial Conduct Authority (the FCA) has published proposed rules and guidance for firms to follow on.

News and Events

Recent Press Releases

Dentons welcomes Jessica Garestier to its Life Sciences group

February 20, 2023

International law firm Dentons is pleased to announce the arrival of Jessica Garestier in its Life Sciences group. Jessica Garestier joins the Life Sciences team as an Of Counsel based in Dentons’ Paris office.