Varond Law & FDA Strategy advises on all FDA regulatory issues but has particular expertise in the following practice areas.
Counsel for pharmaceuticals and biologics, including advanced therapies, across the development lifecycle, from preclinical planning and IND through NDA/BLA approval and post-approval.
FDA regulatory counsel for IPOs, follow-on offerings, M&A, licensing, and public company disclosure, with focused support for life sciences deal teams.
Citizen petitions, exclusivity contests, REMS disputes, FDA rulemaking and policy engagement, and competitive-entry administrative matters.
Promotional review, claim substantiation, scientific exchange, trade complaints, and responses to FDA advertising enforcement.
Varond Law & FDA Strategy serves as FDA regulatory counsel to law firms handling transactions, disputes, investigations, and intellectual property matters involving FDA-regulated products. Corporate firms bring us in on life sciences deals; litigation firms involve us in securities, commercial, patent, and product-liability cases; white-collar firms turn to us on government investigations; and IP counsel involve us in patent, licensing, and exclusivity matters that require FDA regulatory expertise.
As a boutique practice, we often offer a favorable conflict profile and are accustomed to working seamlessly with lead counsel. Our role is to provide practical, specialized FDA judgment in a way that supports lead counsel's role and strengthens the client relationships already in place.