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.

Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.

We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.

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