Alexander Varond

FDA Partner and FDA Litigation Co-Chair, Technology & Life Sciences Group, Goodwin
Summary
Alexander Varond, Partner at Goodwin, serves as the Co-Chair of the firm's FDA Litigation group, specializing in counseling clients in the pharmaceutical and medical device industries.
With a diverse background that includes roles as a project engineer, operations manager, and deputy management representative to the FDA in the medical device sector, Alexander offers a unique perspective in his legal practice.
His expertise spans pre- and post-market issues, encompassing pre-approval strategy, patents, marketing, enforcement, and corporate transactions for clients in pharmaceuticals and medical devices.
Alexander Varond has in-depth experience in advising on orphan drug development, Hatch-Waxman exclusivity, and navigating regulatory compliance matters in the healthcare industry.
His educational background includes a double major in Biomedical Engineering and Management Science from the University of California, San Diego, and he holds J.D. degrees from The George Washington University Law School and the University of San Diego School of Law.
Alexander's practice areas involve prescription drugs, biologics, and medical devices, where he offers strategic guidance on product development, regulatory compliance, submission strategies, and enforcement issues.
Additionally, he assists clients in securing priority review vouchers, breakthrough therapy designations, and drafts citizen petitions to the FDA, ensuring comprehensive support in the regulatory landscape.
In the realm of medical devices, Alexander advises on compliance matters such as labeling, advertising, quality systems regulation, and submission reviews for various applications.
His due diligence expertise extends to conducting thorough assessments for SEC filings and corporate transactions, while also providing regulatory assistance in enforcement actions including investigations and compliance during FDA inspections.
As a seasoned professional, Alexander Varond has previous experience as an Associate at Hyman, Phelps & McNamara, P.C., in addition to roles as a Law Clerk at the U.S. International Trade Commission and as an IP Law Clerk at NuVasive.
Alexander Varond's legal practice showcases his commitment to excellence and comprehensive understanding of FDA regulations, making him a sought-after authority in the field of pharmaceutical and medical device law.