{"product_id":"mocra-enterprise-annual-package","title":"MoCRA Enterprise Annual Package","description":"\u003cp\u003eMoCRA 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.\u003c\/p\u003e\u003ch2\u003eWhat is MoCRA Enterprise?\u003c\/h2\u003e\u003cp\u003eLarge brands face every \u003cstrong\u003eMoCRA\u003c\/strong\u003e duty at scale: \u003cstrong\u003efacility registration\u003c\/strong\u003e for several sites, \u003cstrong\u003eproduct listing\u003c\/strong\u003e for hundreds of SKUs, \u003cstrong\u003eadverse event reporting\u003c\/strong\u003e, \u003cstrong\u003esafety substantiation\u003c\/strong\u003e and labelling. \u003cstrong\u003eEnterprise\u003c\/strong\u003e brings these into one programme with a \u003cstrong\u003ededicated regulatory manager\u003c\/strong\u003e, overseen by \u003cstrong\u003eSyed Muhammad Shamuel Shees, US Regulatory Lead\u003c\/strong\u003e, and can include \u003cstrong\u003eOTC drug\u003c\/strong\u003e and \u003cstrong\u003emedical device\u003c\/strong\u003e work. \u003cstrong\u003eBook a scoping call\u003c\/strong\u003e to start.\u003c\/p\u003e\u003ch3\u003eWhat Enterprise can include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eScale\u003c\/strong\u003e: 100+ SKUs and multiple facilities\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDedicated regulatory manager\u003c\/strong\u003e: One named contact for your programme\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eResponse time\u003c\/strong\u003e: Replies within 1 business day\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLaunch calendar\u003c\/strong\u003e: Planned listings and reviews for new products\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMonthly compliance report\u003c\/strong\u003e: Status of registrations, listings and adverse events\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOTC and device add-ons\u003c\/strong\u003e: Drug and device work scoped in\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho Enterprise is for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eBrands with 100 or more US SKUs\u003c\/li\u003e\n\u003cli\u003eGroups with several manufacturing facilities\u003c\/li\u003e\n\u003cli\u003eBrands with OTC drugs or devices alongside cosmetics\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat Enterprise does not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eA fixed price before scoping.\u003c\/strong\u003e Pricing starts from £15,000 and is confirmed after a scoping call.\u003c\/li\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\u003eFDA fees.\u003c\/strong\u003e Passed through where they apply.\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.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does MoCRA Enterprise Annual Package work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eBook a scoping call\u003c\/strong\u003e: We review your SKUs, facilities and launch plans.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProposal\u003c\/strong\u003e: You receive a written scope and price.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eOnboarding\u003c\/strong\u003e: Agreements, KYC and set-up.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDelivery\u003c\/strong\u003e: Your regulatory manager runs the programme with monthly reports.\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 sections 604–609\u003c\/strong\u003e — MoCRA duties for cosmetics\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSection 612\u003c\/strong\u003e — small business exemptions\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 207\u003c\/strong\u003e — OTC drug registration and listing, where in scope\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 807\u003c\/strong\u003e — device registration and listing, where in scope\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=\"\/nl\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/nl\/products\/mocra-professional-annual-package\"\u003eMoCRA Professional Annual Package\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/mocra-essentials-annual-package\"\u003eMoCRA Essentials Annual Package\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/mocra-product-listing-volume-plans\"\u003eMoCRA Product Listing — Volume Plans\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":"From £15,000 a year — book a scoping call","offer_id":67824695967821,"sku":null,"price":15000.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/mocra-enterprise-annual-package.webp?v=1793176385","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/mocra-enterprise-annual-package","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}