{"product_id":"mocra-professional-annual-package","title":"MoCRA Professional Annual Package","description":"\u003cp\u003eMoCRA 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.\u003c\/p\u003e\u003ch2\u003eWhat is the MoCRA Professional package?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003eMoCRA\u003c\/strong\u003e places most duties on the \u003cstrong\u003eresponsible person\u003c\/strong\u003e: \u003cstrong\u003eproduct listing\u003c\/strong\u003e (FD\u0026amp;C Act section 607(c)), \u003cstrong\u003eserious adverse event reporting\u003c\/strong\u003e within 15 business days (605), \u003cstrong\u003esafety substantiation\u003c\/strong\u003e (608) and a US contact on the label (609). \u003cstrong\u003eProfessional\u003c\/strong\u003e puts \u003cstrong\u003ePhoenix Safety Consultants LLC\u003c\/strong\u003e in that role, alongside the \u003cstrong\u003eUS agent\u003c\/strong\u003e for your facility, with work reviewed by \u003cstrong\u003eSyed Muhammad Shamuel Shees, US Regulatory Lead\u003c\/strong\u003e.\u003c\/p\u003e\u003ch3\u003eWhat's included in Professional?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eEverything in Essentials\u003c\/strong\u003e: Registration, renewal management, US agent and regulatory alerts\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eResponsible person\u003c\/strong\u003e: Phoenix Safety Consultants LLC on your labels, subject to KYC and contract\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAdverse event service\u003c\/strong\u003e: Intake, triage and serious event reports for up to 25 products\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct listings\u003c\/strong\u003e: Up to 25 products, with annual updates\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel reviews\u003c\/strong\u003e: Up to 10 US label and claims reviews\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSafety substantiation review\u003c\/strong\u003e: For up to 10 SKUs\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQuarterly review call\u003c\/strong\u003e: And replies within 2 business days\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho Professional is for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eCosmetic brands with 10–25 US products\u003c\/li\u003e\n\u003cli\u003eBrands that need a US responsible person on the label\u003c\/li\u003e\n\u003cli\u003eBrands selling through US retailers and marketplaces\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat Professional does not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLaboratory testing.\u003c\/strong\u003e Laboratory testing, lab fees and test reports are not included.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOTC drug or device work.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eLegal advice.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA guaranteed FDA date or certificate.\u003c\/strong\u003e 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.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA dedicated regulatory manager.\u003c\/strong\u003e Optional at £1,250 a month.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Professional Annual Package work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eOnboarding\u003c\/strong\u003e: KYC checks and a review of your products, labels and safety data.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreements\u003c\/strong\u003e: 12-month package, US agent and responsible person agreements.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSet-up\u003c\/strong\u003e: Registration, listings and adverse event intake.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eThrough the year\u003c\/strong\u003e: Label and safety reviews, quarterly calls and replies within 2 business days.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 604 and 609\u003c\/strong\u003e — responsible person and label contact\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 605\u003c\/strong\u003e — serious adverse event reporting\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 607\u003c\/strong\u003e — registration, US agent and product listing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 608\u003c\/strong\u003e — safety substantiation\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Modernization of Cosmetics Regulation Act of 2022 (FDA)](https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra)\u003c\/li\u003e\n\u003cli\u003e[Registration and Listing of Cosmetic Product Facilities and Products (FDA)](https:\/\/www.fda.gov\/cosmetics\/registration-listing-cosmetic-product-facilities-and-products)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/fr\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/fr\/products\/mocra-essentials-annual-package\"\u003eMoCRA Essentials Annual Package\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/mocra-enterprise-annual-package\"\u003eMoCRA Enterprise Annual Package\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/us-responsible-person-for-cosmetics-12-months\"\u003eUS Responsible Person for Cosmetics (12 Months)\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Default Title","offer_id":67824695902285,"sku":null,"price":7950.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-professional-annual-package.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/fr\/products\/mocra-professional-annual-package","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}