Buchalter’s FDA Regulatory Compliance Group counsels established, growing and entrepreneurial enterprises whose activities are regulated by the U.S. Food and Drug Administration (FDA) and its counterpart authorities. Our highly experienced team is known for providing comprehensive guidance in all phases of clients’ product development cycle, including:
- Strategic business planning
- Product development and testing
- Product marketing
- Product labeling and ingredient reviews
- FDA Registrations
- Premarket Notifications
- Responses to Warning Letters
- Structure and function claims and more
We also develop and execute comprehensive compliance and risk management strategies for our clients, taking into consideration additional regulatory agency compliance, such as the Federal Trade Commission, and other regulatory authorities.
Buchalter’s FDA Regulatory Compliance Group represents a broad range of industries. These include pharmaceutical, biologic, food and beverage, personal care and cosmetics, dietary supplements, cannabis, medical devices, digital health, and software deemed as a medical device.
What We Do
Buchalter’s counsel aligns to every stage of product development, from product inception through pre-launch, product recalls, and defense of class action and litigation. Our range of services include:
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- compliance and guidance
- Labeling, promotion and advertising
- Consumer complaints
- Contract drafting, review and negotiation
- Litigation, class action defense and disputes
- Compliance analysis and programs
- Product safety, inspections and post-market issues
- FDA warning and enforcement letters
- FDA testing and research
- Due diligence and corporate transactions
- Premarket reviews
- Regulatory strategies for innovative products and technologies subject to FDA compliance
- Nutrient and content claims
- Organic and natural claims
While Buchalter’s regulatory compliance team is often asked to parachute in to manage unforeseen issues, we are equally adept as on call FDA-focused advisors supporting clients as they evolve and scale their products.
We customize compliance programs to clients’ needs, adding comprehensive counsel on cross-border and EU expansion and related concerns on privacy, data and other legal barriers and obligations. We have deep knowledge of the statutory schemes related to FDA guidelines, including the FDCA, FSMA, cGMP’s, False Claims Act, federal and state Controlled Substances Acts, along with state and federal consumer protection related laws and regulations.
Buchalter’s trial-tested products liability law group adds invaluable insights to clients’ strategic planning and defenses to avoid compliance issues and related consumer complaints. However, where avoiding consumer complaints or FDA attention is unavoidable, our team of trial lawyers have decades of experience to protect our clients when faced with litigation and class actions.
Our Clients
Buchalter’s product experience is vast, ranging from bespoke skincare and cannabis-infused soft drinks to novel pharmaceuticals and biologics. Industry sectors include:
- Cosmetics
- Personal care companies
- App-based and customized beauty
- Food
- Beverages
- Cannabis products
- Nutraceuticals
- Dietary supplements
- Over-the-counter drugs (OTC)
- Biologics
- Pharmaceuticals
- Medical devices
- Software as medical device (SAMD)and digital health
From Deal Due Diligence to Strategic Product Expansion
Experience before the FDA, FTC and other regulatory bodies allows us to position clients ahead of the concerns of government overseers. We know the sticking points and stay ahead of shifts in rules and regulations. Our initial reviews of labels, ingredients, websites and marketing are an upfront investment that pays dividends in preventing major, late-stage product changes.
Buchalter attorneys dive deep and focus on the critical questions and solutions to achieve FDA approval and compliance. We advise several technology-driven cosmetic, personal care, device and medical companies and increasingly address the interplay of AI with emerging products and services.
Our FDA regulatory compliance attorneys advise clients, including entrepreneurs across the country, to support the integrity, innovation and introduction of their products seamlessly to the marketplace.
