Contracting in life sciences requires complying with multiple sets of regulations. We build in compliance by design, basing our services on extensive regulatory knowledge and best practices experience.
Counsel on IDE, IND, HDE, HCT/P, informed consent, financial disclosure, IRB and Part 11 regulations and associated FDA guidances.
Structure payments from manufacturers to healthcare providers to help reduce Anti-Kickback Statute and False Claims Act risk. Counsel on subject injury & Medicare Secondary Payer.
Counsel on compliance with HIPAA, state privacy and security laws, and international data protection in connection with clinical research and commercial operations.
Guide clients on disclosure of payments & TOV from manufacturers to healthcare providers per FDA financial disclosure, Sunshine Act, best practices and more. Counsel on clinicaltrials.gov and ICMJE.
Identify and counsel on conflicts of interest and FDA concerns about independence and potential for bias. Advise on journal publications.
Educate clients on EU, Canadian and foreign clinical trials contracting, subject injury, GDPR and data protection, financial disclosure, and anti-kickback/anti-bribery regimes.
Laying a proper foundation for your business operations is key. Our services build compliance in from the start.
We help you navigate the regulatory web through a cohesive, interdisciplinary approach to life sciences contracting. Knowledge of contract law is not enough. We infuse your contracts with regulatory compliance, life sciences industry norms, technology law and practical business considerations.
Government regulations, industry best practices and business needs each play a role. Allow us to help you navigate the regulatory web.