Regulatory Agreements & Transactions

Torrey Pines Law Group's regulatory counsel and advisors have decades of experience with successfully drafting and negotiating regulatory agreements, as well as with developing and implementing regulatory strategies when business transactions involve regulated subject matter. Regulatory agreements create bright lines between parties who intend to run clinical trials, manufacture medical devices and drugs, and share the risk of operating in an environment where patient safety and privacy are paramount.

From the most basic to the most complex, the regulatory attorneys and advisors at Torrey Pines Law Group have experience with regulatory agreements and transactions, including drafting, negotiating, and enforcing a broad range of agreements which impact on regulatory strategy.

More specifically, we have experience with drafting and negotiating regulatory agreements including:

• Clinical Trial Agreements
• Quality Agreements
• Commercialization Agreements
• Sponsored Research Agreements
• Pharmacovigilance Agreements
• Safety Data Exchange Agreements
• Marketing Authorization Holder Agreements

For information on these and other legal, regulatory, and business matters, please contact us.