Navigate FDA drug compliance with confidence as you bring your pharmaceutical product to the U.S. market and tackle a complex regulatory landscape.
Intertek provides expert support to help you meet key FDA requirements, efficiently and accurately. Explore our services designed to keep your products compliant and your business moving forward.
Our Services
- NDC Labeler Code Requests: Secure your FDA-assigned labeler code: the critical first step to marketing your drug in the United States.
- Establishment Registration & Drug Listing: ensure your facilities and products are properly registered and listed with the FDA, fulfilling core obligations under U.S. law.
- CARES Act Reporting of Drug Amounts: stay compliant with the CARES Act by submitting timely reports on quantities of drugs manufactured or distributed.
- GDUFA Self-Identification & User Fee Payment: meet Generic Drug User Fee Amendments (GDUFA) requirements with ease, from facility self-identification to managing fee submissions.
- Over-the-Counter Monograph Drug User Fee (OMUFA): navigate new user fees for OTC drugs under OMUFA to keep your business aligned with evolving regulations.
Why Intertek Assuris?
Rely on our team’s deep regulatory expertise and extensive experience with FDA drug compliance. We provide end-to-end support, managing every detail from application to submission so you can stay focused on your products. Count on us to be responsive and reliable, delivering fast answers and proactive guidance at every step.
Ready to streamline your FDA compliance? Contact us today to discuss your needs and see how we can support your product’s journey to market.
