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Axentra Global Pharma Compliance LLC: Your Global FDA Compliance Partner

Your dedicated U.S. Agent & Regulatory Partner for Drugs, Medical Devices, Cosmetics (MoCRA), and Dietary Supplements.

We simplify U.S. market access: FDA Facility Registration, MoCRA Compliance, SPL Listing, and US Agent Representation.

Our Services

Our Services

At Axentra Global Pharma Compliance LLC, we deliver specialized U.S. Agent, regulatory, and compliance solutions for pharmaceutical, biologics, and nutraceutical manufacturers worldwide. Our comprehensive services ensure FDA compliance and extend to every stage of the regulatory lifecycle—from FDA registration and dossier development to GMP audits and CDMO due diligence, helping manufacturers seamlessly navigate the U.S. and global markets. Axentra Global Pharma Compliance LLC is dedicated to simplifying regulatory complexities for businesses entering the U.S. market.

RLD & Comparator Drug Sourcing with GDP Compliance

Regulatory-assured sourcing of reference listed drugs for ANDA, MAA, biosimilar and complex generic development programs—delivered with full GDP oversight and audit-ready documentation.

FDA Facility Registration

Full Establishment Registration support for Drug & Cosmetic facilities. We manage FurlS (Drugs) and Cosmetics Direct (MoCRA) registrations, renewals, and FEI verification

Dossier Development & eCTD Publishing

CTD/eCTD authoring, compilation, formatting, and publishing across Modules 1–5 for FDA, EMA, MHRA, TGA, and Health Canada.

U.S. Labeling, Artwork & Compliance Review

Fast, expert FDA labeling review for drugs, OTCs, and supplements—covering artwork, NDC formatting, compliance statements, and claim validation to prevent misbranding or import delays.

Cosmetics and MoCRA compliance

Mandatory compliance for the new MoCRA regulations. We handle FDA Cosmetic Facility Registration, Product Listing, Adverse Event Management, and serve as your U.S. Agent for Cosmetics to prevent retail delisting.

Drug Listing & SPL Compliance

We prepare and submit accurate Structured Product Labeling (SPL) files to FDA, maintain drug listings, manage annual certifications, and ensure compliant labeling data throughout your product lifecycle.

U.S. Agent & FDA Representation

Official U.S. Agent representation for Pharma, Medical Devices, Cosmetics, and Dietary Supplements. We act as your liability shield for FDA communication, inspection notices, and MoCRA mandated correspondence. 

Regulatory Strategy & Consulting

Strategic regulatory pathways for IND, NDA, ANDA, and global submissions, along with scientific advice packages and lifecycle planning.

Automated Vaccine Production

Testimonials

“Axentra and their India affiliate provided thorough GMP audits and CDMO evaluations. Their attention to detail and understanding of both U.S. and Indian regulatory systems helped us choose the right manufacturing partner confidently.”

— Chief Operating Officer, Global Biotech Start-Up

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.

Contact

Have questions?

Explore our detailed FAQ section for clear answers on U.S. Agent responsibilities, FDA registration steps, drug listing, SPL requirements, FSVP rules, and more.

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Request a Regulatory/US agent Consultation

1209 MOUNTAIN ROAD PL NE 

STE N

ALBUQUERQUE, NM 87110

Tel. +1-505-358-4858

Email: info@axentracompliance.com

Axentra provides U.S. Agent services, MoCRA Cosmetic Registration, FDA Drug Listing, SPL submissions, and Regulatory Strategy for global manufacturers.

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