Strategic FDA Regulatory Consulting

FDA Compliance
That Goes Beyond
Registration.

Strategic advisory, specialized expertise, and end-to-end accountability across pharmaceuticals, APIs, cosmetics, OTC drugs, and dietary supplements. One point of contact. Your entire regulatory lifecycle.

15+ Years FDA Experience Single Point of Contact Max 3 Projects Per Consultant 24h Expert Response

Foreign Manufacturers Established Exporters U.S. Brands & MoCRA

Get Your Free Regulatory Assessment

Expert response within 24 hours · No obligation · Fully confidential

MoCRA cosmetic facility registration now enforced by FDA FDA facility renewal window: October – December 2026 Non-compliant facilities risk import alerts and shipment detention U.S. Agent required before your first shipment to the United States OTC drug monograph reforms now in effect for 2026 eCTD format mandatory for all NDA, ANDA, and BLA submissions MoCRA cosmetic facility registration now enforced by FDA FDA facility renewal window: October – December 2026 Non-compliant facilities risk import alerts and shipment detention U.S. Agent required before your first shipment to the United States

Who We Serve

Three Types of Client.
One Standard of Expertise.

Whether you are entering the U.S. market for the first time, managing ongoing compliance obligations, or a U.S.-based brand navigating a new regulatory landscape — Axentra provides expert guidance at every stage.

Foreign Manufacturers

Entering the U.S. Market

Pharmaceutical, API, cosmetic, food, or supplement manufacturers — navigating FDA requirements for the first time.

U.S. Agent appointment & FDA facility registration
FEI number, DUNS & UFI acquisition
Drug listing, SPL & NDC labeler codes
Import compliance & pre-shipment label review

Established Exporters

Already in the U.S. Staying Ahead.

Foreign manufacturers with existing U.S. market presence who need ongoing compliance management and strategic regulatory advisory.

Annual registration renewal management
FDA correspondence & inspection readiness
eCTD & CTD dossier authoring
Warning letter response & remediation

U.S. Domestic Brands

Cosmetics, OTC & Personal Care

U.S.-based brands keeping pace with MoCRA, OTC monograph reforms, and evolving FDA enforcement priorities.

MoCRA facility registration & product listing
Responsible Person designation
Adverse event reporting systems
Label & INCI compliance review

Services

Full-Spectrum FDA Regulatory
Services

Specialized depth across every FDA-regulated category — from initial market entry through complex pharmaceutical submissions and beyond.

21 CFR §1.227

U.S. Agent

U.S. Agent Representation

Legally required FDA liaison for all foreign facilities. We receive FDA communications, coordinate inspections, and manage enforcement correspondence without delay.

PharmaFoodCosmeticsDevices

21 CFR §207

Registration

FDA Facility Registration

Drug, food, cosmetic, and dietary supplement facility registration and renewal. FEI number, DUNS & UFI acquisition, and October–December renewal window management.

DrugFoodMoCRASupplements

MoCRA §607

MoCRA

MoCRA Cosmetics Compliance

Full MoCRA compliance — facility registration, product listing, responsible person designation, adverse event reporting, and label ingredient review for cosmetic and personal care brands.

CosmeticsPersonal CareU.S. Brands

21 CFR §207.37

Drug Listing

Drug Listing, SPL & NDC

NDC labeler code assignment, Structured Product Labeling authoring and submission, DRLS drug listing, and OTC monograph compliance for pharmaceutical manufacturers.

OTCRxSPL / NDC

ICH M4 / CTD

Pharma & API

Pharmaceutical & API Compliance

Drug establishment registration, cGMP regulatory strategy, eCTD dossier authoring and publishing for NDA, ANDA, and IND. API master file and Type II DMF support.

NDAANDAAPI / DMFeCTD

21 CFR §201 / 701

Labeling

Label Review & Compliance

Pre-shipment FDA label audits for OTC drugs, cosmetics, dietary supplements, and food — preventing import refusals, misbranding violations, and costly recall exposure.

OTCCosmeticsFoodSupplements

21 CFR §1.500

FSVP

FSVP Agent & Prior Notice

Foreign Supplier Verification Program agent services, FSVP plan development, supplier verification, and FDA Prior Notice filing for food and supplement importers.

FoodSupplementsImporters

21 CFR §111 / DSHEA

Supplements

Dietary Supplement Compliance

DSHEA compliance strategy, cGMP gap assessments, new dietary ingredient notifications, structure-function claim substantiation, and FDA prior notice filing.

DSHEANDIcGMPClaims

The Axentra Model

Built for Depth,
Not Volume.

Every structural decision at Axentra is designed to protect the quality of your engagement — from how we assign consultants to how quickly we respond when it matters most.

Single Point of Contact

One consultant. One relationship. From your first inquiry through registration, listing, label review, and beyond — the same expert manages your account throughout. No re-explaining your situation to someone new. No dropped context between handoffs.

vs. ticket queues and rotating account managers

Maximum Three Projects Per Consultant

Our consultants never manage more than three active engagements at once. This is a firm policy — not a preference. It is how we guarantee that your project receives focused, unhurried attention rather than a fraction of an overloaded schedule.

vs. consultants carrying 50–100 accounts at volume firms

Personal Attention, Guaranteed

Every inquiry is answered by the regulatory expert assigned to your account — not screened by a coordinator, not routed through an automated portal. We commit to a substantive expert response within 24 hours of any issue raised during an active engagement.

vs. 5–10 business day response windows

Specialized, Focused Expertise

Deep domain knowledge across pharmaceuticals, APIs, cosmetics, OTC drugs, and dietary supplements — not a generalist registration portal. We advise on regulatory strategy, not just process paperwork. Our consultants know the CFR, not just the forms.

vs. generalist volume firms with surface-level category knowledge

Side by Side

How Axentra Compares

The difference is structural, not cosmetic. How a firm is organized determines what clients actually experience — and what their regulatory outcomes look like.

High-Volume Firms

Axentra Global

Client Contact

Rotating staff, ticket-based support, frequent handoffs

One dedicated consultant from day one — no handoffs, ever

Consultant Capacity

50 to 100+ active accounts per consultant, often more

Maximum three active engagements per consultant — firm policy

Response Time

5 to 10 business days standard; expedited carries a surcharge

24-hour expert response — guaranteed, no surcharge

Depth of Advice

Checklist completion and form submission; limited strategic input

Regulatory strategy, pathway decisions, and risk advisory

Domain Expertise

Generalist — food, drugs, devices handled the same way

Specialized depth: Pharma, API, OTC, Cosmetics, Supplements

Fee Structure

Hourly billing, scope creep, unpredictable invoices

Fixed-fee proposals — scope and cost agreed upfront

Immediate Action Required · U.S. Cosmetic Brands

MoCRA Registration Deadlines
Have Passed. Are You Compliant?

The Modernization of Cosmetics Regulation Act introduced the most sweeping changes to U.S. cosmetics law in over 85 years. Facility registration and product listing deadlines have passed. Brands that remain unregistered face FDA enforcement action, import alerts, and disruption to their U.S. sales.

FDA facility registration & product listing under MoCRA
Responsible Person designation and documentation
Adverse event reporting system setup and management
Label & INCI ingredient compliance review

Get MoCRA Compliant

Free compliance assessment
Expert response within 24 hours

How It Works

From First Inquiry
to Full Compliance.

A clear, three-step engagement. No discovery calls that lead nowhere. No vague proposals. Just expert assessment and a transparent fixed-fee roadmap — delivered promptly.

Submit Your Inquiry

Tell us your product category, country of origin, and compliance need using either form on this page. It takes under two minutes and requires no prior commitment.

Under 2 minutes

Free Expert Assessment

A senior FDA regulatory expert reviews your situation and responds within 24 hours with a substantive assessment of your obligations, risks, and recommended regulatory pathway — at no charge.

Within 24 hours

Fixed-Fee Proposal & Roadmap

You receive a transparent, fixed-fee proposal and a complete regulatory roadmap. Scope and cost are agreed upfront — no hourly billing, no surprises. We proceed only when you are ready.

Transparent pricing

Start Today