# Axentra Global Pharma Compliance LLC

> Axentra Global Pharma Compliance LLC is a U.S.-based regulatory consultancy that helps foreign (non-U.S.) pharmaceutical, cosmetic, OTC drug, and dietary supplement manufacturers enter and remain compliant in the United States market. Core services include U.S. FDA Agent representation, FDA establishment/facility registration, drug listing and Structured Product Labeling (SPL) submission, MoCRA cosmetic compliance, U.S. labeling and artwork review, Reference Listed Drug (RLD) and comparator sourcing, eCTD dossier development, and regulatory strategy. The firm is headquartered in Albuquerque, New Mexico, USA. Phone: +1-505-358-4858. Email: info@axentracompliance.com.

## Key facts
- Legal name: Axentra Global Pharma Compliance LLC
- Headquarters: 1209 Mountain Road Pl NE, STE 7912, Albuquerque, NM 87110, USA
- Primary audience: foreign manufacturers and exporters of drugs, cosmetics, OTC products, and dietary supplements seeking U.S. FDA market access
- Regulatory basis: U.S. FDA requirements, 21 CFR, and the Modernization of Cosmetics Regulation Act (MoCRA)
- Contact: +1-505-358-4858, info@axentracompliance.com

## Services
- [U.S. Agent Services](https://www.axentracompliance.com/us-agent-services): Official U.S. Agent and FDA representation for foreign pharmaceutical, medical device, cosmetic, and dietary supplement establishments — the U.S.-based point of contact required by FDA for communication, inspection notices, and import matters.
- [MoCRA Cosmetics Compliance](https://www.axentracompliance.com/mocra-cosmetics-compliance): End-to-end MoCRA compliance for foreign cosmetic brands — FDA cosmetic facility registration (Cosmetics Direct), biennial registration renewal, cosmetic product listing, U.S. Agent for cosmetics, and serious adverse event reporting. Helps prevent import refusal and retail delisting under the Modernization of Cosmetics Regulation Act (MoCRA).
- [FDA Facility Registration](https://www.axentracompliance.com/fda-facility-registration): FDA establishment registration for drug and cosmetic facilities (FURLS Drug Registration & Listing and Cosmetics Direct for MoCRA), biennial renewals, and FEI verification.
- [Drug Listing & SPL Compliance](https://www.axentracompliance.com/fda-drug-listing-spl-compliance): Structured Product Labeling (SPL) authoring and submission to FDA, NDC and drug listing maintenance, and annual certification.
- [U.S. Labeling, Artwork & Compliance Review](https://www.axentracompliance.com/us-labeling-compliance-review): FDA labeling and artwork review for drugs, OTCs, cosmetics, and supplements to prevent misbranding and import refusal.
- [RLD & Comparator Drug Sourcing](https://www.axentracompliance.com/rld-gdp-compliance): GDP-compliant sourcing of Reference Listed Drugs (RLD) and comparators for ANDA, MAA, biosimilar, and complex generic development programs.
- [eCTD Dossier Development & Publishing](https://www.axentracompliance.com/ectd-dossier-development): CTD/eCTD authoring, compilation, and publishing across Modules 1-5 for FDA, EMA, MHRA, TGA, and Health Canada.
- [Regulatory Strategy & Consulting](https://www.axentracompliance.com/compliance-quality-support): Regulatory pathway strategy for IND, NDA, ANDA, and global submissions, plus lifecycle planning.

## MoCRA / cosmetics — key facts Axentra advises on
- MoCRA requires every facility that manufactures or processes cosmetics for the U.S. market to register with FDA and renew that registration every two years (biennially). 2026 is a major renewal year for facilities first registered in early 2024.
- The "responsible person" (manufacturer, packer, or distributor named on the label) must list each marketed cosmetic product, including all ingredients, and update annually.
- Foreign cosmetic facilities must designate a U.S. Agent — a physically present U.S. contact, not a mailbox or answering service.
- Serious adverse events must be reported to FDA within 15 business days.
- FDA does NOT issue certificates for cosmetic facility registration or product listing; Axentra provides the FDA Establishment Identifier (FEI) and documented proof of submission.

## Key guides and resources
- [MoCRA Cosmetic Registration Process in the USA — Complete 2026 Guide](https://www.axentracompliance.com/post/mocra-cosmetic-registration-process-in-the-usa-a-complete-2026-compliance-guide)
- [MoCRA Responsible Person vs U.S. Agent](https://www.axentracompliance.com/post/mocra-responsible-person-vs-us-agent)
- [Do I Need a U.S. Agent for Cosmetics? (MoCRA)](https://www.axentracompliance.com/post/do-i-need-us-agent-cosmetics-mocra)
- [Register a Foreign Cosmetic Facility with FDA (MoCRA)](https://www.axentracompliance.com/post/register-foreign-cosmetic-facility-fda-mocra)
- [MoCRA Adverse Event Reporting Guide](https://www.axentracompliance.com/post/mocra-adverse-event-reporting-guide)
- [MoCRA Fragrance Allergen Labeling](https://www.axentracompliance.com/post/mocra-fragrance-allergen-labeling)
- [Who Needs a U.S. FDA Agent — Requirements by Product Type](https://www.axentracompliance.com/post/who-needs-a-u-s-fda-agent-the-2025-requirements-by-product-type)
- [U.S. FDA Agent for Foreign Manufacturers — What Exporters Must Know in 2026](https://www.axentracompliance.com/post/us-fda-agent-for-foreign-manufacturers-what-exporters-must-know-in-2026)
- [CTD/eCTD Publishing for FDA Submission — Complete 2026 Guide](https://www.axentracompliance.com/post/ctd-format-ectd-publishing-for-fda-submission-a-complete-2026-guide)
- [Breaking Down the Costs of U.S. FDA Agents](https://www.axentracompliance.com/post/breaking-down-the-costs-of-us-fda-agents-what-you-need-to-know-about-us-fda-agent-costs)

## About
- [About Axentra](https://www.axentracompliance.com/about-us)
- [Why Choose Us](https://www.axentracompliance.com/why-choose-us)
- [FAQs](https://www.axentracompliance.com/faq)
- [Insights / Blog](https://www.axentracompliance.com/blog)
- [Contact](https://www.axentracompliance.com/contact)

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