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Axentra Global Pharma Compliance LLC - Your Experts in Navigating FDA Compliance

Experience seamless FDA compliance with Axentra Global Pharma Compliance LLC, your trusted partner for navigating U.S. market regulations. Offering services like MoCRA compliance, FDA facility registration, and U.S. Agent representation, Axentra Global Pharma Compliance LLC ensures your business achieves regulatory success. Choose Axentra Global Pharma Compliance LLC to simplify your compliance process today.

Our Services

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.

Cosmetics and MoCRA compliance

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

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.

FDA Facility Registration

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

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. 

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.

Regulatory Strategy & Consulting

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

Dossier Development & eCTD Publishing

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

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.

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?

Chat with us , Email us , Use our contact form , Call us or simply 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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