Email address
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+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 advised Insmed on its request for Orphan Drug Designation from FDA for its novel gene therapy.
Provided by Chambers
The team at Cooley is rigorous, knowledgeable, thoughtful and took a prudent approach in a potentially sensitive matter.
They are really responsive, have a great knowledge base and they come from previous government roles, which is useful.
We find Cooley to be entrepreneurially minded and commercially oriented while providing sound legal guidance.
They are practical, pragmatic and efficient. I need someone who knows the law inside and out to advise me on the path forward. Cooley is my go-to for that kind of advice.
The team at Cooley is rigorous, knowledgeable, thoughtful and took a prudent approach in a potentially sensitive matter.
They are really responsive, have a great knowledge base and they come from previous government roles, which is useful.
We find Cooley to be entrepreneurially minded and commercially oriented while providing sound legal guidance.
They are practical, pragmatic and efficient. I need someone who knows the law inside and out to advise me on the path forward. Cooley is my go-to for that kind of advice.
Provided by Chambers
Sonia Nath is an experienced pharmaceutical and medical device lawyer. She combines extensive white-collar experience with a deep understanding of FDA regulations to provide advice on inspections, investigations and compliance.
Sonia is one of the few lawyers who was both a criminal and a civil litigator for the agency. She's my go-to for FDA advice these days.
Whenever I have an FDA regulatory question, she is my go-to person. She knows everything, literally.
Sonia is is extremely well-versed in regulation, she always has a proactive approach and provides a highly supportive structured engagement.
Eric is an outstanding lawyer and policy mind who is able to untangle complex healthcare matters and successfully advocate for his clients.
Eric provides confidence in the process and guides you smoothly through a challenging workflow.
Eric is a true standout in the depth and breadth of his knowledge.
Eric stands out as a trusted adviser who brings not only exceptional legal skill but a deep, intuitive understanding of our business priorities.