Companies regulated by the FDA face continuous government scrutiny and encounter a range of legal, regulatory and business challenges, whether they are just starting out or have been in operation for decades. Our attorneys are well equipped to help FDA-regulated companies manage these challenges, as we possess a wealth of firsthand knowledge about critical life cycle matters including product development, manufacturing and supply, and commercialization.
Our teams of FDA-focused attorneys collaborate seamlessly across practices encompassing:
- Intellectual Property
- Privacy and Data Security
- Labor and Employment
- Corporate Law
BakerHostetler attorneys integrate real-world experience and expertise that is both broad and deep. This enables us to tailor our counsel to meet the unique needs of our clients and help them develop strategies to manage risk at all stages of their products’ life cycles.
We work closely with executive management teams; regulatory affairs; compliance and legal departments; corporate boards of directors; private equity funds; medical and safety review committees; and institutional review boards, regularly assisting clients with matters involving:
- Pharmaceuticals and Biologics
- Medical Devices and Diagnostics
- Food and Dietary Supplements
- Emerging Technologies
- Cosmetics
- Tobacco