Helping our clients navigate every aspect of the complex and evolving FDA regulatory landscape

With you from the first step to the last. 

RMMS recognizes that regulatory matters are directly tied to our client’s business and commercialization goals, that’s why we partner with them through every stage of a product’s lifecycle to develop differentiated regulatory strategies, that align with their patent defenses and litigation strategies, to put our clients in the best position in competitive landscapes.

We work with agencies like we work with our clients. 

At the core of our practice is a nuance understanding of the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act (FDCA) and biosimilars, under the Public Health Service Act (PHSA) and Biologics Price Competition and Innovation Act (BPCIA). We regularly advise on expedited FDA review strategies for drugs and biological products, including matters related to the appropriate regulatory pathway, patent listing and certification issues, product labeling, agency review requirements, risk management programs, marketing exclusivities, and citizen petitions, just to name a few.

Through written submissions (both private controlled correspondence and the public citizen petition process) and meetings with agency personnel, our attorneys have successfully persuaded the FDA to, among other things:

We have extensive experience challenging or defending agency decision-making in federal courts

RMMS attorneys have extensive experience facilitating market access through in suits filed under the Administrative Procedures Act both at the district court and appellate levels. We have been involved in a number of regulatory actions involving FDA/HHS aimed at delaying our clients’ approval and marketing based on unlawful claims of exclusivity, unnecessary labeling requirements, and dubious statutory arguments:

Regulatory HighlightsView All

More and more leaders in the life sciences industry are turning to RMMS for successful outcomes.

Here’s what they have to say.

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