Email address
[email protected]Contact number
+1 202 842 7800Provided by Chambers
Cooley LLP is recognized for its robust practice, providing FDA-related regulatory advice for a range of clients in the healthcare sphere, including pharmaceutical companies, medical device companies and digital health companies. It is also sought out for other regulatory, legal and compliance support in the life sciences space.
Cooley LLP represented Liquidia Technologies in filing a lawsuit under the Administrative Procedure Act against FDA following the agency not allowing patients access to the client's drug, Yutrepia, because it concluded that a competing drug, Tyvaso DPI, enjoys continued market exclusivity.
Provided by Chambers
The team has strong knowledge of the topics and nuances, great acumen and client relationships, providing a great service level and responsiveness.
The firm has stellar attorneys who come from the FDA and bring deep knowledge and experience. Their advice is practical and demonstrates a deep understanding of the law, regulations and their purpose.
The firm understands my needs, connecting me with resources to find solutions and giving actionable feedback in a timely manner. The team understands the market.
Cooley provides timely responses that are aligned with our needs and proactive engagement on matters. It has been able to work on all of our needs seamlessly and is always timely and thorough.
The team has strong knowledge of the topics and nuances, great acumen and client relationships, providing a great service level and responsiveness.
The firm has stellar attorneys who come from the FDA and bring deep knowledge and experience. Their advice is practical and demonstrates a deep understanding of the law, regulations and their purpose.
The firm understands my needs, connecting me with resources to find solutions and giving actionable feedback in a timely manner. The team understands the market.
Cooley provides timely responses that are aligned with our needs and proactive engagement on matters. It has been able to work on all of our needs seamlessly and is always timely and thorough.
Provided by Chambers
Sonia is extremely knowledgeable and experienced with an extremely good handle on FDA rules and regulations and how to apply them while not impeding business growth.
Sonia is a powerhouse, a customer-focused individual. She has my needs front and center and delivers qualified, actionable advice in a timely manner.
Sonia is a rockstar. She is super smart with excellent judgment, and can handle anything.
Eric has deep expertise and knowledge along with a 'dig in deep' approach to highly complex legal matters. He is able to resolve in a practical, smart, business-oriented way.
Eric keeps the bigger picture in mind and is detail-oriented when required.