FDA counsel for drug & biologic development
Varond Law & FDA Strategy helps life sciences sponsors get drugs and biologics approved, and navigate stakeholders through critical regulatory milestones and strategic transactions.
Built for life sciences companies navigating the FDA at pivotal moments.
Regulatory Strategy
We help clients anticipate regulatory challenges early, defining the right pathway before committing resources. Our strategies are built on deep FDA precedent knowledge and hands-on experience.
Industry & Government Insight
With experience in industry, government, and leading life sciences law firms, we bring a rare perspective that bridges the gap between companies, investors, and the FDA.
Patient-Centered Counsel
We believe deeply that every regulatory decision should be made with patients in mind. Our board service in rare disease advocacy and focus on orphan drug development reflect this conviction.
Practice Areas
Drug & Biologic Development
Counsel for pharmaceuticals and biologics, including advanced therapies, across the development lifecycle, from preclinical planning and IND through NDA/BLA approval and post-approval.
Learn More →Corporate Transactions & Investor Diligence
FDA regulatory counsel for IPOs, follow-on offerings, M&A, licensing, and public company disclosure, with focused support for life sciences deal teams.
Learn More →FDA Policy, Advocacy & Administrative Disputes
Citizen petitions, exclusivity contests, REMS disputes, FDA rulemaking and policy engagement, and competitive-entry administrative matters.
Learn More →Advertising & Promotion
Promotional review, claim substantiation, scientific exchange, trade complaints, and responses to FDA advertising enforcement.
Learn More →Selected Rankings and Awards
Alexander Varond
FDA Regulatory Counsel
Alex Varond is a nationally recognized FDA regulatory lawyer focused on drug and biologic development, high-stakes FDA engagement, and life sciences transactions. He brings nearly two decades of experience at the intersection of FDA law, regulatory science, and life sciences strategy.
Before founding Varond Law & FDA Strategy, he co-chaired Goodwin's FDA litigation practice and served as a partner in the firm's life sciences group. He is admitted to practice in California and the District of Columbia.
Full biography →Let's discuss your regulatory needs.
Whether you're navigating a high-stakes FDA decision, planning a development program, or evaluating a transaction, we're ready to help.
Please do not send confidential or time-sensitive information before a conflict check has cleared and a written engagement letter is in place. An inbound email alone does not create an attorney-client relationship.