MoCRA Professional Annual Package
A 12-month MoCRA package with Phoenix Safety Consultants LLC as US agent and responsible person, adverse event handling and safety review.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
MoCRA Professional is a 12-month package for growing cosmetic brands. It includes everything in Essentials plus Phoenix Safety Consultants LLC as responsible person, an adverse event service for up to 25 products, up to 25 listings, 10 label reviews, safety substantiation review for 10 SKUs and quarterly calls, with a 2-business-day response time. £7,950 a year.
What's included in Professional
| Document | What it is |
|---|---|
| Everything in Essentials | Registration, renewal management, US agent and regulatory alerts |
| Responsible person | Phoenix Safety Consultants LLC on your labels, subject to KYC and contract |
| Adverse event service | Intake, triage and serious event reports for up to 25 products |
| Product listings | Up to 25 products, with annual updates |
| Label reviews | Up to 10 US label and claims reviews |
| Safety substantiation review | For up to 10 SKUs |
| Quarterly review call | And replies within 2 business days |
Who Professional is for
- Cosmetic brands with 10–25 US products
- Brands that need a US responsible person on the label
- Brands selling through US retailers and marketplaces
What Professional does not include
- Laboratory testing. Laboratory testing, lab fees and test reports are not included.
- OTC drug or device work. Available separately.
- Legal advice.
- A guaranteed FDA date or certificate. FDA processing time varies and is outside our control, so we do not guarantee a date. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.
- A dedicated regulatory manager. Optional at £1,250 a month.
How it works
- Onboarding KYC checks and a review of your products, labels and safety data.
- Agreements 12-month package, US agent and responsible person agreements.
- Set-up Registration, listings and adverse event intake.
- Through the year Label and safety reviews, quarterly calls and replies within 2 business days.
What is the MoCRA Professional package?
MoCRA places most duties on the responsible person: product listing (FD&C Act section 607(c)), serious adverse event reporting within 15 business days (605), safety substantiation (608) and a US contact on the label (609). Professional puts Phoenix Safety Consultants LLC in that role, alongside the US agent for your facility, with work reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
What Professional covers over 12 months
Roles:
- US agent and responsible person: Phoenix Safety Consultants LLC.
Filings and reviews:
- Listings: Up to 25 products.
- Adverse events: Up to 25 products, reports within 15 business days.
- Label reviews: Up to 10.
- Safety review: Up to 10 SKUs.
Support:
- Quarterly review call and replies within 2 business days.
What you receive
- Registration and listing numbers once issued
- Signed US agent and responsible person agreements
- Adverse event process and log
- Label and safety review reports
- Quarterly review notes
Legal framework
- FD&C Act section 604 and 609 — responsible person and label contact
- Section 605 — serious adverse event reporting
- Section 607 — registration, US agent and product listing
- Section 608 — safety substantiation
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix Professional
- US agent and responsible person from one team.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
- Replies within 2 business days.
Book Professional. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What does MoCRA Professional include?
Everything in Essentials, plus Phoenix Safety Consultants LLC as responsible person, adverse events for up to 25 products, up to 25 listings, 10 label reviews, safety review for 10 SKUs and quarterly calls.
Is the responsible person role guaranteed?
It is subject to KYC checks, a review of your products and a signed contract.
What response time does Professional have?
We reply within 2 business days. Serious adverse event reports are filed within the 15-business-day legal limit.
Can I add a dedicated regulatory manager?
Yes, for £1,250 a month.
Is testing included?
No. Laboratory testing, lab fees and test reports are not included.
How much does Professional cost?
£7,950 a year, with a 12-month minimum. FDA fees, if any, are extra.