March 7, 2025. Buchalter is pleased to announce the launch of its FDA Regulatory Compliance Group, dedicated to guiding clients through the complex regulatory landscape of the U.S. Food and Drug Administration (FDA) and related agencies. This new practice group provides strategic counsel, from inception to marketing, compliance, and litigation defense.
Buchalter’s launch of the FDA Regulatory Compliance Group demonstrates the firm’s commitment to staying at the forefront of regulatory changes and providing a broader range of services to clients, especially those in highly regulated sectors. There is growing regulatory complexity and enforcement across numerous industries, and the need for qualified regulatory counsel only continues to intensify. With the increase in FDA scrutiny—particularly in biotech, digital health, and personal care—companies must navigate evolving regulations to ensure compliance and mitigate risk.
“Buchalter is always looking ahead to anticipate and meet our clients’ evolving legal needs,” said Adam Bass, Chief Executive Officer of Buchalter. “With regulatory oversight expanding across industries, the launch of this group allows us to provide the sophisticated counsel our clients require to innovate and grow. Under Marissa’s leadership, our team is well positioned to help clients navigate these challenges.”
The FDA Regulatory Compliance Group will be led by practice Chair Marissa Alkhazov, a seasoned trial attorney with extensive experience in product liability defense, regulatory compliance, and risk management. Alkhazov leads a highly experienced team known for providing comprehensive guidance across all phases of clients’ product development cycle.
"With heightened enforcement, emerging technologies, and increased client demand, we’ve seen a growing number of companies seeking assistance with FDA matters,” said Alkhazov. “Our team understands the ever-evolving regulatory landscape and the increasing need for sophisticated FDA counsel. We are committed to helping clients navigate complex regulations, mitigate risks, and bring their products to market with confidence.”
Buchalter’s FDA Regulatory Compliance Group offers a full suite of legal services, including product labeling and ingredient reviews, FDA registrations, compliance strategies, premarket notifications, defense against FDA warning letters, and regulatory guidance under MoCRA and other evolving statutes. In addition, the team provides proactive risk management solutions to help clients stay ahead of regulatory changes and avoid costly enforcement actions.
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Buchalter is a full-service business law firm representing local, regional, national, and international clients in a multitude of practice areas and their subspecialties, among them: Bank and Finance, Corporate, Health Care, Litigation, Insolvency and Financial Law, Intellectual Property, Labor and Employment, Real Estate, and Tax and Estate Planning. Buchalter has approximately 550 attorneys with offices in California, Arizona, Colorado, Georgia, Illinois, Oregon, Tennessee, Utah, and Washington. For more information about the firm, visit: buchalter.com.
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