Overview
I am most impressed by their ability to distill complex regulatory guidance into manageable pieces that my organization can use as the basis for implementing needed changes.
– Chambers USA
Experienced Counsel to Guide You Through Industry Growth
Whether you’re a life sciences industry giant or a startup, changes to cybersecurity, pharmaceuticals, medical devices, patient rights and transformative ventures present great opportunities for industry growth, but also new—and sometimes daunting—challenges for your organization. Intense financial penalties, negative rulings and individual accountability are only a few of the risks life sciences companies face if they do not understand and remain compliant with these ever-changing regulations.
Our global team of regulatory lawyers work with you to create and implement practical plans to anticipate and mitigate potential risks; respond to inquiries by state, national and international agencies; and, if necessary, pursue resolution of disputes in court and before administrative and other tribunals in a way that least disrupts your business.
Our mission-first approach, coupled with proven experience, helps drive the success of your initiatives:
- Obtaining antitrust and other approvals for acquisitions and licensing
- Clinical trial development
- Product application and review
- Manufacture, marketing and reimbursement of drug, biologic, device and other products
- US Food and Drug Administration (FDA) review
- Good Manufacturing Practice (cGMP)
- Advertising and promotion
- Supply chain and distribution, including pricing programs
- Post-market surveillance
- Internal compliance program implementation and monitoring
- Resolution of issues arising from clinical trial oversight
- Inspections, compliance and enforcement investigations and actions of the FDA, US Department of Justice (DOJ), other federal and state agencies, and Congress, as well as qui tam and other litigation
Our global team of top lawyers combines the market intelligence and proven experience of our Tier 1 health practice with our deep bench of lawyers from our FDA; food, beverage and agribusiness; antitrust; environmental; corporate and securities; and other core practices. Working together, we help clear your path to success.
Let us make compliance easier for you.