FDA regulatory consulting
Supporting FDA compliance across food, packaging, and OTC products
Bringing food, drug, and packaging products to market in the U.S. means navigating a complex and evolving regulatory landscape. The U.S. Food and Drug Administration (FDA) oversees a wide range of product categories – from food ingredients and contact materials to topical antiseptics and hand sanitizers – each with its own compliance requirements.
Sagentia Regulatory provides science-led, strategic support to help companies meet FDA expectations efficiently and confidently. Whether you’re pursuing GRAS status, submitting a food contact notification, or ensuring your OTC topical antiseptic product aligns with monograph standards, we guide you through every step of the regulatory process.
GRAS, food additive, and food contact compliance
Bringing food ingredients and packaging materials to market in the U.S. requires navigating complex FDA regulations. Sagentia Regulatory supports clients with GRAS determinations, food additive petitions, and food contact notifications – ensuring compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA). We help companies meet premarket approval requirements, prepare robust scientific submissions, and respond to FDA queries. Whether you’re introducing a novel ingredient or packaging material, our team provides strategic, science-led guidance to streamline approvals and reduce regulatory risk.
Our services include:
- Preparing and submitting GRAS notifications and self-determination dossiers
- Convening expert panels to assess GRAS status
- Developing and submitting Food Additive Petitions (FAPs)
- Preparing and submitting Food Contact Notifications (FCNs)
- Supporting end-use testing of food contact substances
- Creating dietary exposure models and conducting risk assessments
- Reviewing toxicological, chemical, and environmental data
- Advising on labeling and claims compliance
- Supporting establishment registration and FDA liaison
- Aligning with international food contact regulations, where applicable
Why choose Sagentia Regulatory?
At Sagentia Regulatory, we combine scientific depth with regulatory precision to help you navigate FDA requirements with confidence. Our consultants bring decades of experience across food, packaging, and OTC drug categories – ensuring your submissions are not only compliant, but strategically positioned for success. We understand the nuances of FDA pathways and work closely with your team to anticipate challenges, streamline approvals, and reduce time to market. Whether you’re pursuing GRAS status, a food contact notification, or OTC drug compliance, we offer responsive, science-led support tailored to your innovation goals.
North American regulatory support
Supporting North American market access. Discover our expertise
European regulatory support
Expert regulatory support for European markets. Explore our services
Expert insights
Explore our archive of expert advisories on crop protection, antimicrobial and chemical regulations.