MoCRA Enterprise Annual Package
A scoped 12-month MoCRA programme for large brands with many SKUs and facilities. Book a scoping call.
- 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 Enterprise is a 12-month programme for brands with 100 or more SKUs or several facilities. It adds a dedicated regulatory manager, a 1-business-day response time, a launch calendar, monthly compliance reports and optional OTC and device work. Pricing starts from £15,000 a year and is confirmed after a scoping call.
What Enterprise can include
| Document | What it is |
|---|---|
| Scale | 100+ SKUs and multiple facilities |
| Dedicated regulatory manager | One named contact for your programme |
| Response time | Replies within 1 business day |
| Launch calendar | Planned listings and reviews for new products |
| Monthly compliance report | Status of registrations, listings and adverse events |
| OTC and device add-ons | Drug and device work scoped in |
Who Enterprise is for
- Brands with 100 or more US SKUs
- Groups with several manufacturing facilities
- Brands with OTC drugs or devices alongside cosmetics
What Enterprise does not include
- A fixed price before scoping. Pricing starts from £15,000 and is confirmed after a scoping call.
- Laboratory testing. Laboratory testing, lab fees and test reports are not included.
- FDA fees. Passed through where they apply.
- Legal advice.
- A guaranteed FDA date or certificate. FDA processing time varies and is outside our control, so we do not guarantee a date.
How it works
- Book a scoping call We review your SKUs, facilities and launch plans.
- Proposal You receive a written scope and price.
- Onboarding Agreements, KYC and set-up.
- Delivery Your regulatory manager runs the programme with monthly reports.
What is MoCRA Enterprise?
Large brands face every MoCRA duty at scale: facility registration for several sites, product listing for hundreds of SKUs, adverse event reporting, safety substantiation and labelling. Enterprise brings these into one programme with a dedicated regulatory manager, overseen by Syed Muhammad Shamuel Shees, US Regulatory Lead, and can include OTC drug and medical device work. Book a scoping call to start.
How Enterprise is scoped
We scope:
- SKUs and facilities.
- Roles: US agent and responsible person through Phoenix Safety Consultants LLC.
- Launch calendar and review volumes.
- OTC and device needs.
Service levels:
- Replies within 1 business day.
- Monthly compliance report.
What you receive
- A written scope and price after the scoping call
- A dedicated regulatory manager
- Monthly compliance reports
- A launch calendar
Legal framework
- FD&C Act sections 604–609 — MoCRA duties for cosmetics
- Section 612 — small business exemptions
- 21 CFR Part 207 — OTC drug registration and listing, where in scope
- 21 CFR Part 807 — device registration and listing, where in scope
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix Enterprise
- One programme for cosmetics, OTC and devices.
- Overseen by Syed Muhammad Shamuel Shees, US Regulatory Lead.
- Replies within 1 business day.
Book a scoping call. Order above to reserve your call, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What does MoCRA Enterprise include?
A dedicated regulatory manager, replies within 1 business day, a launch calendar, monthly compliance reports and optional OTC and device work, for 100+ SKUs and multiple facilities.
How much does Enterprise cost?
From £15,000 a year. The final price is confirmed after a scoping call.
How do I start?
Book a scoping call. We review your SKUs, facilities and launch plans, then send a written scope and price.
Can Enterprise include OTC drugs and devices?
Yes. OTC drug and device registration, listing and label work can be scoped in. Testing is excluded.
Who oversees the programme?
Syed Muhammad Shamuel Shees, US Regulatory Lead oversees the programme, with a dedicated regulatory manager as your day-to-day contact.
Is there a minimum term?
Yes, 12 months.