Global Cosmetic Regulatory Support

At Concept 2 Clinic, we provide end-to-end regulatory support for cosmetic brands, helping you launch your products seamlessly in Canada, U.S., EU, and UK. Whether you need guidance on compliance, product registration, or connecting with a local Responsible Person (RP) or safety assessor, we have trusted partners to make your journey smooth.

Canada

We ensure compliance with Health Canada and Consumer Product Regulations:

1. Guidance on whether your product is classified as a cosmetic or NHP
2. Cosmetic Notification Form (CNF) submission to Health Canada
3. Review of ingredient safety, fragrance allergens and labeling requirements
4. Ensuring claims compliance to avoid drug classification
5. Advance Notice of Importation and Health Canada communications
6. Post-market support including adverse event reporting and compliance updates

United States

We navigate the post MoCRA U.S. regulatory landscape:

1. Facility registration
2. Product listing with FDA for each cosmetic product
3. Guidance on ingredient safety, prohibited substances and color additives
4. Annual contract with U.S. agents to handle FDA communications
5. Labeling and claims compliance to avoid drug classification
6. Adverse event reporting and recordkeeping
7. Guidance on Good Manufacturing Practices (cGMP) for quality assurance
8. Ongoing monitoring of regulatory changes in the U.S.

European Union

We provide full support for selling cosmetics in the EU with compliance assurance:

1. Appointing our trusted EU Responsible Person (RP)
2. Preparation and submission of the Cosmetic Product Notification Portal (CPNP) notification
3. Conducting a safety assessment by a qualified safety assessor
4. Compilation of a Product Information File (PIF) for regulatory compliance
5. Ingredient compliance, including restricted or banned substances
6. Ensuring labeling compliance in local EU languages
7. Guidance on substantiated cosmetic claims
8. Support for Good Manufacturing Practices (ISO 22716) compliance
9. Assistance with adverse event reporting to competent authorities

United Kingdom

We help brands comply with UK Cosmetics Regulations post-Brexit:

1. Appointing our trusted UK Responsible Person (RP) if your company is outside the UK
2. Notification of cosmetic products via the UK Submit Cosmetic Product Notification (SCPN) portal
3. Ingredient safety and restricted substances
4. Assistance with labeling compliance
5. Support for product safety assessments via trusted partners.
6. Review of claims compliance to avoid medicinal/drug classification.
7. Advice on Good Manufacturing Practices (GMP)
8. Assistance with post-market vigilance and adverse event reporting
9. Continuous monitoring of UK regulatory updates for cosmetics.

Your One-Stop Cosmetics Regulatory Partner!

From Canada to the U.S., EU, and UK, we simplify the regulatory process so you can focus on growing your cosmetic brand. With our trusted partners, RPs, and safety assessors, we provide a compliant, and seamless solution.