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With our international footprint and the unmatched breadth and depth of our regulatory practice groups, Hogan Lovells handles the most challenging issues involving clinical trials. You can rely on our leading specialists for advice on compliance with applicable regulatory requirements, including the Good Clinical Practice and Good Laboratory Practice standards, pharmacovigilance procedures, and assistance in developing strategies for regulatory approval and life cycle management. We also have the resources around the world to quickly and efficiently negotiate all of the agreements needed to initiate global clinical studies. Similarly, we frequently assist our clients in structuring and negotiating clinical research collaboration agreements with government bodies.
We also provide reimbursement advice and assistance in structuring research budgets to ensure compliance with applicable statutes, such as the U.S. Medicare fraud and abuse laws and international anti-corruption laws. Additionally, our product liability practice is not limited to approved products, but can be of great assistance in structuring clinical trials to avoid liability at an early stage.
Our cross-disciplinary approach, the deep bench of talent we have in virtually every discipline, and our knowledge of and contacts with U.S., European, and Asian government agencies enable us to help clients conduct clinical trials globally and achieve their long-term business objectives. Wherever and whenever you need clinical trial support, we are able to assist you with dedicated and experienced life sciences lawyers as well as our in-house science unit.
