These Terms of Service ("Terms") govern the use of the website care-europe.com and the regulatory consulting services provided by CARE — Consultants en Analyse et Recherche pour l'Europe ("Care Europe", "we", "us", "our"), a SIREN-registered French entity with its registered office at 3 Boulevard de Sebastopol, 75001 Paris, France.

By accessing our website or engaging our services, you ("Client", "you") agree to be bound by these Terms. If you do not agree, please do not use our website or services.

1. Services

Care Europe provides EU regulatory consulting services including, but not limited to:

EU regulatory strategy and dossier preparation for pharmaceutical, cosmetic, and food supplement products
GMP compliance consulting (ISO 22716, EU GMP Annex guidelines)
REACH compliance assessment for cosmetic and chemical products
Cosmetic Product Safety Report (CPSR) coordination and Responsible Person services
European market entry consulting for North American brands
Export compliance consulting for EU brands entering the USA and Canadian markets
ISO 17025 quality system consulting for testing laboratories

The specific scope of services for each engagement is defined in a separate Service Agreement or Statement of Work ("SOW") agreed in writing between Care Europe and the Client.

2. Engagement and Acceptance

A consulting engagement begins upon written acceptance of a proposal or SOW by both parties, or upon receipt of a deposit payment where applicable. These Terms are incorporated by reference into all Service Agreements.

3. Fees and Payment

Fees are set out in the applicable proposal or SOW and are quoted in Euros (EUR) unless otherwise agreed.
Invoices are payable within 30 days of the invoice date unless otherwise specified in the SOW.
Late payments bear interest at the statutory rate under French commercial law (Article L. 441-6 of the French Commercial Code), currently 3 times the legal interest rate, plus a fixed recovery indemnity of €40 per invoice.
Care Europe reserves the right to suspend services for overdue accounts after 15 days' written notice.

4. Client Obligations

The Client agrees to:

Provide accurate, complete, and timely information necessary for the performance of services
Notify Care Europe promptly of any changes that may affect the regulatory strategy or product formulation
Obtain all necessary rights and permissions for materials provided to Care Europe
Comply with all applicable laws and regulations in their jurisdiction

5. Confidentiality

Both parties agree to keep confidential all non-public information received from the other party in connection with the services. This obligation survives termination of the engagement for a period of 5 years. Confidential information does not include information that is publicly available, independently developed, or required to be disclosed by law or regulatory authority.

6. Intellectual Property

Upon full payment of all fees, the Client owns the deliverables specifically created for them under the SOW. Care Europe retains ownership of all pre-existing methodologies, templates, tools, and know-how used in the delivery of services. Nothing in these Terms grants the Client any rights to Care Europe's proprietary methodologies.

7. Limitation of Liability

Care Europe's regulatory consulting services are advisory in nature. Final regulatory decisions rest with the competent authorities (EMA, ANSM, EFSA, FDA, Health Canada, etc.). Care Europe does not guarantee regulatory approval of any product or dossier.

To the maximum extent permitted by applicable law, Care Europe's total liability to the Client for any claim arising out of or in connection with the services shall not exceed the total fees paid by the Client for the specific engagement giving rise to the claim in the 12 months preceding the claim.

Care Europe shall not be liable for any indirect, incidental, special, consequential, or punitive damages, including loss of profits, loss of data, or loss of business opportunity.

8. Disclaimer of Warranties

Services are provided "as is" and "as available". Care Europe makes no warranty that regulatory submissions will be approved or that regulatory timelines will be met, as these are subject to factors outside Care Europe's control.

9. Termination

Either party may terminate a Service Agreement with 30 days' written notice. The Client shall pay for all services rendered up to the date of termination. Care Europe may terminate immediately for non-payment or material breach of these Terms.

10. Force Majeure

Neither party shall be liable for delays or failure to perform resulting from circumstances beyond their reasonable control, including acts of God, regulatory authority actions, pandemic, war, or natural disaster.

11. Governing Law and Jurisdiction

These Terms and all Service Agreements are governed by French law. Any dispute arising in connection with these Terms shall be subject to the exclusive jurisdiction of the Commercial Court of Paris (Tribunal de Commerce de Paris), unless mandatory consumer protection laws in the Client's jurisdiction provide otherwise.

Note: In the event of any conflict between the English and French versions of these Terms, the French version shall prevail.

12. Modifications

Care Europe reserves the right to modify these Terms at any time. Updated Terms will be posted on this page with a revised date. Continued use of our services after the effective date of changes constitutes acceptance of the updated Terms.

13. Contact

For questions about these Terms, please contact:

Care Europe
3 Boulevard de Sebastopol, 75001 Paris, France
Email: [email protected]
Phone: +33 1 72 97 31 89