Varond Law & FDA Strategy acts as FDA regulatory counsel for corporate transactions and investor diligence. Our clients span founders and early-stage companies to sophisticated institutional investors.
We work with leading law firms and corporate deal teams that need focused FDA regulatory support on transactions involving drug, biologic, device, and other FDA-regulated companies, serving as the FDA regulatory specialist on the deal.
We serve as FDA regulatory counsel on company-side and underwriter-side IPOs, follow-on offerings, credit and debt facilities, and royalty and other structured financings. We draft and review the regulatory disclosures and risk factors in S-1s and offering documents, and provide regulatory opinions where appropriate.
We conduct FDA regulatory diligence on development, manufacturing, marketing, and compliance risk. For drugs and biologics, this includes assessing preclinical and clinical development programs, approval pathways, potential labeling and indications, likelihood of approval, GxP compliance, REMS and other marketing limitations, and manufacturing and quality risk. For targets and licensors, we help prepare for and respond to these diligence requests. We draft and review the regulatory provisions of merger agreements, asset purchase agreements, and license agreements.
We support public companies and securities counsel by drafting and reviewing FDA-related disclosures in Forms 10-K and 10-Q, press releases, investor presentations, and other public statements.
We advise fund managers, analysts, and other investment professionals on the practical meaning of FDA milestones, agency news, and regulatory developments. This includes parsing what corporate disclosures actually say (and don't say) about a program's regulatory status, advisory committee likelihood, and approval path.
We help early-stage companies build out regulatory plans that match their stage, runway, and financing strategy, while anticipating the diligence questions investors and partners will ask. This helps management explain the regulatory pathway clearly in investor meetings, pitches, and board discussions, and make development decisions with a better understanding of regulatory risk and opportunity.
Alexander Varond has deep experience in corporate transactions and investor diligence. He has served as lead FDA regulatory counsel on dozens of company-side and underwriter-side life sciences IPOs and SPACs representing transaction value of well over $5 billion in aggregate. He has assisted on hundreds of follow-on offerings, ATMs, credit and debt facilities, and other financings, and served as lead FDA reviewer of corporate disclosure for more than three dozen public companies. He has provided FDA regulatory review on numerous M&A deals representing aggregate transaction value of more than $15 billion. In 2022, he led the FDA regulatory review of Intellia Therapeutics' $690 million underwritten public offering, which received LMG Life Sciences' Deal of the Year award.
Alex draws on his combined drug-development and corporate-transactions experience to counsel investors and companies on the impact of FDA regulatory developments, both as disclosed by individual companies and as industry-wide regulatory shifts. His diligence work routinely addresses regulatory exclusivities and follow-on competition risk, and how those factors affect deal terms, valuation, and disclosure.
Alex regularly advises early-stage companies and serves as a mentor through programs such as the California Life Sciences FAST advisory program for innovation and entrepreneurism. He helps founders frame regulatory pathways, identify value inflection points, and find opportunities to de-risk development programs ahead of financings, partnerships, and FDA milestones.