Most elite FDA practices have impressive credentials. At Vedder, we think that’s just the start.
A Different Approach to FDA Counsel
The value of FDA counsel is more than just identifying applicable laws and regulations. It is having the judgment to turn real-world regulatory considerations into clear, actionable advice that advances our clients’ practical business objectives.
Vedder’s FDA Regulatory Strategy & Compliance Practice combines decades of deep FDA knowledge with firsthand execution experience. We have mapped the legal landscape of the Food, Drug & Cosmetic Act and its implementing regulations. We have had a front row seat to evolving FDA policies, enforcement trends, and industry benchmarks. We have advised life sciences businesses from startups to mature international corporations, from the inside and outside. We have diligenced hundreds of life sciences companies across regulated industries and understand the range of market practices. We have been active members of, and board advisors to, industry associations. The result is FDA counsel with the perspective to help our clients make informed business decisions that maximize commercial opportunity while managing risk.
Strategic Counsel Throughout the Product Lifecycle
Product Development & Regulatory Strategy
We help clients evaluate regulatory pathways, product classifications, development considerations, evidence strategies, premarket submissions, and commercialization approaches.
Manufacturing & Quality Systems
We counsel clients on cGMP requirements, supplier oversight, manufacturing operations, imports and exports, inspections, and ongoing operational compliance.
Marketing, Advertising & Promotional Compliance
We help companies evaluate marketing strategies, product claims, packaging and labeling, advertising materials, social media, influencer activities, and the intersection of FDA requirements with FTC and state consumer protection considerations.
Regulatory Inspections & Enforcement
When regulatory issues arise, we provide strategic representation in FDA inspections, Form 483 responses, Warning and Untitled Letters, recalls, investigations, DOJ matters, and related proceedings.
Post-Market Compliance & Ongoing Operations
We help clients address ongoing regulatory obligations, including quality systems, adverse event reporting, product lifecycle management, corrective and preventive actions, field actions, and evolving regulatory requirements.
Sophisticated Deal Counsel for Transactions & Strategic Investments
Transactional Opportunity, De-Risking & Regulatory Due Diligence
Life sciences transactions uniquely require subject matter expertise for two reasons: first, because enterprise value hinges on the ability to market highly-regulated products free of enforcement; and second, because understanding the nooks and crannies of regulatory law often evinces unseen opportunities and competitive advantages. As a result, FDA issues can directly affect valuation, transaction structure, financing, and integration planning. We advise buyers, sellers, investors, lenders, and strategic partners on regulatory diligence, compliance assessments, transaction risk allocation, and post-closing regulatory strategy, always looking to the tenor of the deal and our clients’ goals.
Vedder has substantial experience shepherding life sciences deals from initial tire-kicking to post-event activities in Startup/Venture, Lower Middle, Middle, and Upper Middle Markets. Importantly, we calibrate our work to fit the tenor of the deal and our clients’ goals.
- M&A
- Divestitures & Carve-Outs
- Equity & Ownership Transactions
- Private Equity
- Venture Capital & Emerging Companies
- Joint Ventures & Strategic Relationships
- Commercial Transactions
- Finance Transactions
- Restructuring & Distressed Transactions
- Capital Markets Transactions
- Real Estate & Infrastructure Transactions
- Intellectual Property Transactions
- Cross-Border Transactions
Industries We Serve
Pharmacy, Compounding & Pharmaceuticals
Brand-name and generic prescription drugs, OTC medicines, cannabis, psychedelics and emerging therapies, and 503A and 503B compounding pharmacies.
Medical Devices, Diagnostics, Digital Health & Radiation-Emitting Technologies
Medical devices, diagnostic tests, software as a medical device (SaMD), AI-enabled technologies, telehealth platforms, laboratory products, surgical and hospital equipment, imaging equipment, and lasers.
Dietary Supplements, Food & Beverage & Consumer Health
Vitamins, nutritional supplements, functional and medical foods, conventional foods and beverages, dietary ingredients, infant formula, and everyday consumer health products like sunscreen and toothpaste.
Cosmetics, Personal Care & Aesthetic Wellness
Cosmetics, topical skin care products, aesthetic devices, medical spas, wellness businesses, and personal care products.
Tobacco, Nicotine & Alternative Products
Traditional tobacco, electronic nicotine delivery systems (vape), synthetic and tobacco-derived modern oral nicotine, nicotine pouches, and other alternative nicotine products.
Veterinary & Agricultural Sciences
Pet and agricultural foods, feeds, and medicines.
Integrated Across Vedder’s Platform
FDA-regulated activities do not exist in a vacuum – they require a successful business built around them. Our FDA Regulatory Strategy & Compliance Practice works seamlessly with attorneys across the firm who tailor their advice to the specific needs of life sciences companies:
- Corporate & M&A
- Venture Capital & Private Equity
- Finance
- Intellectual Property
- Commercial Transactions & Licensing
- Litigation & Product Liability
- Government Investigations
- Labor & Employment
- Fintech
- Tax
From our Washington, DC office, we also closely monitor legislative, regulatory, and enforcement developments affecting FDA-regulated industries and assist clients in advocacy matters involving federal agencies, the FDA, and state regulators when changing policy or enforcement priorities affect their businesses.
Vedder also maintains connections to a deep network of subject matter experts who can be nimbly added to our team on an as-needed basis, including professionals with scientific, medical, engineering, pharmacy, and manufacturing expertise.
By integrating regulatory compliance strategy with transactional, litigation, and business counseling, Vedder helps FDA-regulated companies navigate complex legal challenges while advancing their commercial objectives throughout the entire product lifecycle.
Vedder: Helping Companies Make Better Decisions in FDA Matters, When FDA Matters.
