U.S. Services
PRODUCT SAFETY
Our qualified experts evaluate your products and ingredients against the rigorous EU safety standard, as MoCRA doesn’t specify required tests or documentation to prove product safety. We can assist in creating a safety profile for your product by working with third-party testing labs, collecting and validating documentation from your manufacturers and working with toxicologists to draft a Cosmetic Product Safety Report (CPSR) established in accordance with the European Cosmetics Regulation EC No. 1223/2009. We help provide economical solutions to help your business grow while ensuring you are placing safe, efficacious products on market.
Modernization of Cosmetic Regulation Act (MoCRA)
We provide a variety of services to assist our clients with MoCRA compliance efforts, including:
Facility FEI and Registration: All manufacturers of cosmetic products are now required to list their facilities as an FDA regulated establishment and receive an FEI number. Additionally, cosmetic manufacturers, depending on their business size, are also required to register their facility in the Cosmetics Direct portal. Let CCG help you navigate the complicated process.
U.S. Agent Services: For our international clients, CCG can act as your designated U.S. agent to assist with FDA internal policy compliance including FEI registration and Cosmetic Direct registration.
Cosmetic Product Listing: As a requirement of MoCRA, products must be listed 120 days post-marketing in the United States. Let CCG assist you in placing your products on market by listing your cosmetic products in Cosmetics Direct. We’ve helped hundreds of clients with this service, and our knowledgeable experts can help you make this process easy and painless.
Adverse Events: We’ll review recordkeeping procedures, design and implement adverse event receiving procedures and work closely with your customer service teams. CCG is familiar with Gorgias, Zendesk, Gladly and other customer experience services.
FDA Enforcement: We help ensure FDA compliance by evaluating your recall procedures, developing strategies that align with current FDA requirements and providing support during potential enforcement actions at your facility.
Safety: Our experts review your current formulations for compliance, develop strategic testing plans, collaborate with third-party testing facilities, create comprehensive Product Information Files (PIFs) and recommend effective strategies for new product development.
Good Manufacturing Practice Requirements: Through our partnership with a German auditing firm, we provide exclusive access to trained, certified auditors with over 30 years of experience. These experts conduct comprehensive audits of your record keeping and procedures, perform gap analyses against current ISO standards and assist in developing customized processes and procedures—all on a cost-effective, per-project basis.
We offer GMP and capability audits for your contract manufacturers. We can also conduct audits based on your company’s specific standards or help organize third-party retailer audits required by companies like Target and Walmart Responsible Sourcing.
Canada Services
We provide Canada Responsible Person (CRP) Services for non-Canadian cosmetic manufacturers and brand owners, including: Providing your Canadian address and contact information on cosmetic notifications to comply with Section 30(2)(f) of Canadian Cosmetic Regulations.
Communication with Regulatory Authorities, responding to and forwarding communications from Health Canada and other Canadian authorities.
Submitting client responses to regulatory authorities in a timely manner.
Acting as the official point of contact for Canadian regulatory matters.
Label and ingredient review for compliance with Canadian Cosmetic Regulations, maintaining documentation of approved product labels and reviewing product information for regulatory compliance.
Notifying all cosmetic products with Health Canada prior to import, maintaining secure electronic documentation for all registered products, managing product listings and authorization statements and keeping detailed records for regulatory compliance purposes.
NHP & DIN Regulatory & Quality Services for brands seeking to enter the Canadian market with Natural Health Products or Drug Identification Number products. Our team handles product license applications with Health Canada, formulation compliance reviews, label development according to Canadian regulations and site license submissions when required. We manage product classification determinations, assist with ingredient assessments, prepare safety and efficacy documentation and serve as your Canadian regulatory contact. From pre-market assessment through post-approval compliance, our experts navigate Health Canada’s regulatory framework, allowing you to market your NHPs and DIN products in Canada efficiently and compliantly.
EU, U.K. and International Services
We offer services that help ensure that cosmetic products meet the varying regulatory requirements across international markets, minimizing compliance risks and facilitating smooth market entry.
Unique Partnerships
Local Responsible Person (RP) representation in the EU and U.K.
Regulatory expert partnerships across international markets.
Distributor relationships and compliance networks.
Collaborative arrangements with testing laboratories.
Toxicological Safety Assessment Services
Comprehensive Product Information File (PIF) development.
Qualified safety assessor evaluations of formulations.
Ingredient toxicology profile analysis and risk assessment.
Safety margin calculations for all product ingredients.
Exposure scenario evaluation based on product usage.
Assessment against more stringent EU safety standards.
Product Registration
CPNP (EU Cosmetic Products Notification Portal) submissions.
U.K. SCPN (Submit Cosmetic Products Notification) portal registrations.
Country-specific product notifications (e.g., ASEAN systems).
Responsible Person services for product traceability.
REACH registration support for applicable ingredients.
Monitoring and updating registrations as needed.
Ingredient & Label Review
Cross-market compliance analysis of formulations.
Restricted substance and banned ingredient screening.
Concentration limit verification for controlled ingredients.
Claims substantiation documentation.
Multi-language labeling requirements.
Symbol and pictogram compliance.
Ingredient naming convention alignment (INCI/local requirements).
Allergen disclosure verification.
International Market Entry
Market-specific regulatory strategy development.
Gap analysis between current and target market requirements.
Compliance roadmaps for multiple market entry.
Documentation preparation for customs clearance.
Import license facilitation.
Local language translation of regulatory documentation.
Market-specific testing requirements identification.
Ongoing regulatory monitoring and updates service.
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