These terms govern your use of Regulatory Copilot (“the Service”), operated by Regulatory Copilot (“we”, “us”). By creating an account you agree to them. If you are agreeing on behalf of a company, you confirm you are authorised to bind it.
Regulatory Copilot is a documentation and workflow tool. It does not provide legal or regulatory advice and does not guarantee any FDA outcome. Fees, timelines, and requirements shown in the product are illustrative planning estimates. Confirm current requirements with FDA and a qualified professional.
Three points that follow from that, and that we would rather say here than have you discover later:
You are responsible for the accuracy of your account details, for keeping your password secure, and for activity under your account. Tell us promptly if you believe an account has been compromised. Access during the founding-cohort period is by invitation.
You keep all rights to the device data, documents, and records you put into the Service. You grant us only the licence needed to host, process, and display that content in order to operate the Service for you, including sending relevant excerpts to our AI provider when you use an AI feature, as described in our privacy policy.
You are responsible for having the right to upload what you upload, and for not putting protected health information or other regulated personal data into the Service. It is not designed to hold it.
Do not use the Service to break the law, infringe anyone's rights, upload malware, attempt to access another customer's workspace, probe or overload our infrastructure, or resell access without our agreement. Automated access should go through the documented API using your own credentials, at a reasonable rate.
The Service is early software offered to a small group of first customers. During this period:
We take reasonable care to keep the Service running and your data intact, but we do not warrant uninterrupted availability. Keep your own copies of anything you would be unable to reconstruct. Export your records regularly; a regulatory submission should never exist only inside one vendor's system.
Except where the law does not allow it, the Service is provided “as is” and “as available”, without warranties of any kind, express or implied, including any implied warranty of merchantability, fitness for a particular purpose, non-infringement, or accuracy. We do not warrant that the Service will meet a regulatory requirement applicable to you, or that its output is error-free.
To the maximum extent permitted by law, neither party is liable for indirect, incidental, special, consequential, or punitive damages, or for lost profits, revenue, data, or regulatory or business opportunity, however caused.
Our total aggregate liability arising out of or relating to these terms or the Service is limited to the greater of the amounts you paid us in the twelve months before the claim, or one hundred US dollars (US$100). During the founding-cohort period, when no fees are charged, that means US$100.
You agree to indemnify us against third-party claims arising from your content, your use of the Service in breach of these terms, or your regulatory filings.
You may stop using the Service at any time and ask us to delete your workspace. See the privacy policy for how deletion works and what is retained. We may suspend or terminate access for breach of these terms, or if we discontinue the Service, giving reasonable notice and a chance to export your data where we can.
We may update these terms. Material changes will be notified to account holders by email, and the date at the top will change. Continuing to use the Service after a change means you accept it.
These terms are governed by the laws of the State of Delaware, United States, without regard to its conflict-of-laws rules. The state and federal courts located in Delaware have exclusive jurisdiction, and both parties consent to venue there.
If any provision is held unenforceable, the rest remains in force. Our failure to enforce a provision is not a waiver of it. You may not assign these terms without our consent; we may assign them in connection with a merger or sale of assets. These terms, together with the privacy policy, are the entire agreement between us regarding the Service.