Services
Axentra Global Pharma Compliance LLC specializes in providing comprehensive FDA compliance and regulatory solutions for organizations aiming to access the U.S. market efficiently. As a trusted partner, we simplify compliance with services like MoCRA cosmetic compliance, FDA Drug Listing, and U.S. Agent representation, ensuring seamless market entry and ongoing adherence to regulatory requirements. Axentra Global Pharma Compliance LLC is dedicated to guiding your business with expertise and reliability.
U.S. Agent Services
FDA requires every foreign establishment to name a U.S. Agent with a physical U.S. address. We are that point of contact for drug, device, cosmetic and dietary supplement registrations — receiving FDA correspondence, answering inspection and import questions, and staying reachable in U.S. business hours so a notice never sits unanswered.
FDA Facility Registration
Establishment registration for foreign cosmetic, drug, food, and supplement facilities.
MoCRA Cosmetics Compliance
Cosmetic facility registration, product listing, and U.S. Agent under MoCRA.
MoCRA cosmetic product listing and US labels
OTC Drug & Sunscreen Registration
Drug establishment registration, listing/SPL, and Drug Facts. Sunscreen is an OTC drug, not a cosmetic.
Dietary Supplement FDA Compliance
Food-facility registration, U.S. Agent, FSVP, and Supplement Facts.
Drug Listing & SPL Compliance
We build and submit your SPL files to FDA, keep drug listings current, file the annual listing certification, and update label data whenever a formulation, NDC, or establishment detail changes — so your NDCs stay active and your products stay listed.
Ready to Appoint Your U.S. Agent?
Connect with our regulatory experts to discuss FDA registration, dossier planning, or GMP compliance strategies. Let’s make your global submissions simpler and faster.