Terms of Service

1. Overview

These Terms of Service (“Terms”) govern access to and use of Assurentry's websites, client portal, tools, and services (collectively, the “Services”). “Assurentry,” “we,” or “us” refers to the Assurentry entity identified in your order or invoice.

By using the Services, you agree to these Terms. If you use the Services on behalf of an entity, you represent that you have authority to bind that entity, and “you” includes that entity.

2. Description of Services; Scope

Assurentry provides U.S. Agent services for foreign facilities in Food, Medical Devices, Drugs, and Cosmetics (MoCRA), acting as a communications point with the U.S. FDA consistent with applicable regulations (e.g., 21 CFR 1.227; 807.40; 207.69; FD&C Act §607).

Assurentry is not the U.S. FDA, is not affiliated with the FDA, and does not provide legal advice or guarantee regulatory approvals or outcomes.

• You may receive an Assurentry U.S. Agent Acceptance Letter confirming our appointment as your facility's U.S. Agent. The U.S. FDA does not issue “certificates of registration.”
• FSVP Importer responsibilities are separate and not included.
• Services do not include Responsible Person (cosmetics), importer of record, prior notice filings, or legal advice. Optional add-ons may be offered separately.

3. Accounts, Eligibility, and Use

You must be at least the age of majority in your jurisdiction and authorized to bind your organization. Provide accurate information and keep credentials confidential. You are responsible for activity under your account.

4. Orders, Fees, and Taxes

Unless stated otherwise in an order, U.S. Agent fees are $399/year per facility for all product categories (Food, Devices, Drugs, and Cosmetics). Fees are non-refundable once onboarding and issuance of the Acceptance Letter occurs, except as required by law. You are responsible for any applicable taxes, duties, or bank fees. Pricing and taxes may vary by jurisdiction and currency.

5. Term; Termination

Each subscription term is one year from the effective date on your order or invoice and renews as stated in your order. Either party may terminate for material breach not cured within 30 days' written notice. We may suspend Services for non-payment or misuse. Upon termination or non-renewal, we will cease acting as your U.S. Agent and you must update your FDA records.

6. Customer Obligations

You will: (a) provide accurate facility and contact information; (b) promptly inform us of changes; (c) respond to requests reasonably required to fulfill U.S. Agent duties; and (d) comply with applicable laws. You are responsible for your content and for obtaining any consents necessary to share personal data with us.

7. Confidentiality

Each party will protect the other party's Confidential Information using reasonable care and use it only as permitted by these Terms. Confidential Information excludes information that is public, independently developed, or lawfully obtained from a third party.

8. Data Protection & Security

Our Privacy Policy describes how we collect and process personal data. We implement reasonable administrative, technical, and physical safeguards. You remain the controller of your data. Where required, we will sign a Data Processing Addendum (DPA).

9. Third-Party Services

The Services may interoperate with third-party providers (e.g., email or hosting vendors). We are not responsible for third-party services or content.

10. Disclaimers

THE SERVICES ARE PROVIDED “AS IS.” TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. WE DO NOT WARRANT THAT THE SERVICES WILL MEET YOUR REQUIREMENTS OR BE ERROR-FREE.

11. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, NEITHER PARTY WILL BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR LOST PROFITS, EVEN IF ADVISED OF THE POSSIBILITY. OUR TOTAL LIABILITY UNDER THESE TERMS WILL NOT EXCEED THE AMOUNTS PAID BY YOU FOR THE SERVICES IN THE 12 MONTHS BEFORE THE EVENT GIVING RISE TO LIABILITY.

12. Indemnification

You agree to defend and indemnify us against third-party claims arising from your (a) unlawful use of the Services; (b) violation of these Terms; or (c) infringement or violation of third-party rights, except to the extent caused by our breach of these Terms.

13. Export & Sanctions

You represent that you are not subject to U.S. sanctions and will not use the Services in violation of export control or sanctions laws.

14. Changes to the Services or Terms

We may update the Services and these Terms from time to time. If changes are material, we will notify you by reasonable means. Continued use after effective date constitutes acceptance.

15. Governing Law; Dispute Resolution

These Terms are governed by the laws of Delaware, USA, without regard to conflicts of law. The parties will first attempt to resolve disputes informally.

(Optional): Any unresolved dispute shall be submitted to binding arbitration in Wilmington, Delaware, under the Rules of the American Arbitration Association. (Consult counsel before enabling arbitration/class-action waiver.)

16. Miscellaneous

These Terms constitute the entire agreement regarding the Services and supersede prior understandings. Assignment requires written consent (not to be unreasonably withheld). If any provision is unenforceable, the remainder remains in effect. Notices must be in writing to support@assurentry.com unless otherwise specified.

17. Contact

Assurentry
Email: support@assurentry.com
Assurentry, United States