Terms of Use, Use Policy and Disclaimer
These terms apply to the Norte Regulatorio website (norteregulatorio.com), newsletter and issues, free recall lookup, Market Radar, Norte index, paid subscription plans (Individual, Team and Executive Watch) including watchlist alerts and monthly briefs, and the “AI Kit for Complaints, CAPA and 8D” (the “Kit”), including its Claude Skills, Excel templates, prompts and related content (together, the “Services”; and all content, data, signals, indices, templates and downloadable files provided through the Services, the “Materials”). By accessing, subscribing to, purchasing or using the Services, you agree to these terms. If you do not agree, do not use the Services. A Spanish version is available; see Sections 18 and 19.
1. Purpose: Educational Guidance Only
The Materials are educational guides and drafting aids. They are not a validated system for managing complaints, CAPA, 8D reports, design-assurance records, risk-management files, or any other quality-system record. They are not a medical device, not quality-system software validated for any intended use, and not a substitute for your organization’s approved procedures, controlled forms, and validated systems.
You must use your organization’s own approved systems and procedures for all regulated records. If you use the Materials to prepare a draft, a qualified person in your organization must review and correct it, and must enter the final record in your own validated system before any decision or action is taken.
2. No Legal, Regulatory, Investment or Professional Advice
The Materials are informational only. They are not legal, regulatory, medical, tax, financial, investment, or compliance advice, and they do not create an attorney-client, consultant, fiduciary, advisory, or broker relationship between you and us.
The Materials do not determine whether an event is reportable (for example, under 21 CFR Part 803), whether a recall, correction, or removal is required, or whether any system, process, or product complies with 21 CFR Part 820 / QMSR, ISO 13485, ISO 14971, NOM-241-SSA1-2025, or any other law, standard, or requirement. Those decisions belong solely to authorized personnel in your organization and, where appropriate, qualified legal or regulatory counsel. Do not delay, forgo, or alter any regulatory decision, report, or action because of the Materials.
Market Radar, indices and indicators. The Market Radar, the Norte index and any color-coded or other indicator are rule-based summaries of public records (for example, FDA recall records, FDA warning letters and publicly announced leadership changes) using the published method shown on the relevant page. They are general publications, not individualized investment advice. They are not a rating, credit or quality opinion, recommendation, solicitation, offer, or forecast, and they are not personalized to your circumstances or objectives. They do not measure a company’s product quality, safety, legal compliance or financial performance. A recall or warning letter does not by itself indicate wrongdoing. Do not buy, sell, or hold any security, or take any other financial action, because of the Materials. Consult a licensed professional.
3. Public Data, Sources, Verification and Corrections
Data and quotations come from public sources (for example, openFDA, FDA web pages, the Federal Register, COFEPRIS, SEC filings, and third-party market-data sites) and are accessed on the dates stated. Sources may change, be revised, be delayed, or be incomplete, and we do not guarantee they are current. A recall record is not a recall event. Company matching uses the firm name as the source records it, so results may include related entities or miss records filed under a different name. Categorizations, trends, summaries, indicators, and mappings to regulatory sections are our own analysis, not official classifications or agency positions. You must verify every fact at the official source before relying on it. We have no obligation to update the Materials after publication.
If you believe a fact in the Materials is wrong or out of date, email hola@norteregulatorio.com with the page, the statement and the official source. We will review it promptly and correct confirmed errors.
4. AI-Generated Output
The Skills use third-party large language models and can produce errors, omissions, outdated information, or fabricated details (“hallucinations”). Outputs may also vary between runs. All outputs are unverified drafts. You are solely responsible for reviewing, validating, and approving any output before use. Test the Materials with fictitious data before any real use. We do not control third-party AI services, and their availability, behavior, and terms are outside our responsibility.
5. Your Data and Confidentiality
Do not enter patient information, personal data, protected health information, trade secrets, or confidential information of your employer or any third party into the Materials or any AI tool unless your organization’s policies, your agreements, and applicable law allow it. Anonymize all inputs. You are solely responsible for what you submit and for compliance with your employer’s policies, confidentiality obligations, and applicable data-protection laws. We do not receive or process content you enter into AI tools or templates on your own systems, unless you send it to us. Our collection and use of website, newsletter, and payment data is described in our Privacy Notice (Aviso de Privacidad) at norteregulatorio.com/privacy.
6. Independence and No Endorsement
Norte Regulatorio is an independent publication. It is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration, COFEPRIS, or any government agency, nor by any employer, manufacturer, or supplier of the author or of any user, nor by any company named in the Materials. Agency and company names are used only to identify public information and remain the property of their owners. Views expressed are those of Norte Regulatorio only and not of any current or former employer of its author or contributors.
7. Assumption of Risk and No Reliance
You use the Services at your own risk. You acknowledge that you are a professional or business user (or are acting in a professional capacity), that you have not relied on any statement outside these terms, and that you will exercise independent professional judgment. Results and outcomes (including inspection, audit, certification, regulatory, or investment results) are not promised or guaranteed. For consumers in Mexico, Section 19 applies.
8. Disclaimer of Warranties
TO THE EXTENT PERMITTED BY LAW, THE SERVICES AND MATERIALS ARE PROVIDED “AS IS” AND “AS AVAILABLE,” WITHOUT WARRANTIES OF ANY KIND, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WARRANTIES OF ACCURACY, COMPLETENESS, TIMELINESS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. WE DO NOT WARRANT THAT THE SERVICES OR MATERIALS WILL BE ERROR-FREE, UNINTERRUPTED, DELIVERED ON TIME, OR SUITABLE FOR REGULATED OR INVESTMENT USE.
9. Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY LAW, NORTE REGULATORIO, ITS OWNERS, OFFICERS, EMPLOYEES, CONTRACTORS, AND AFFILIATES WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, OR PUNITIVE DAMAGES, OR FOR ANY LOSS OF PROFITS, REVENUE, DATA, BUSINESS, GOODWILL, INVESTMENT VALUE, OR REGULATORY STANDING, OR FOR REGULATORY ACTIONS, FINES, RECALLS, OR PENALTIES, ARISING OUT OF OR RELATED TO THE SERVICES OR MATERIALS, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. OUR TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS RELATING TO THE SERVICES OR MATERIALS WILL NOT EXCEED THE GREATER OF (A) THE AMOUNT YOU PAID US FOR THE SERVICES IN THE 12 MONTHS BEFORE THE CLAIM AROSE OR (B) US$100.
Some jurisdictions do not allow certain exclusions or limits, so these apply only to the extent permitted by law. Nothing in these terms excludes liability that cannot be excluded, or waives any right that cannot be waived, under applicable law, including mandatory consumer protection law. For consumers in Mexico, Section 19 applies.
10. Indemnification (Business Users)
If you use the Services on behalf of, or for the purposes of, a business or organization, then to the extent permitted by law you agree to defend, indemnify, and hold harmless Norte Regulatorio and its owners, officers, employees, and contractors from third-party claims, damages, losses, and expenses (including reasonable attorneys’ fees) arising from your breach of these terms, your violation of any law or third-party right, or any record, decision, report, or submission you make using the Materials. This Section does not apply to consumers within the meaning of the Mexican Ley Federal de Protección al Consumidor, or to anyone to whom the law does not permit it to apply.
11. License and Permitted Use
Subject to these terms and payment of applicable fees, we grant you a limited, non-exclusive, non-transferable, revocable license to use the Materials for your own personal or internal business purposes.
- Single-user license: one named individual.
- Team plan: up to five (5) named individuals within one organization, as stated at purchase. The account holder is responsible for their team’s compliance.
You may not: (a) resell, sublicense, share, publish, or redistribute the Materials or any part of them, including download pages and passwords; (b) use them to build, train, or market a competing product or service; (c) remove copyright, attribution, or disclaimer notices; (d) access the Services by automated means (such as scraping or bulk extraction) beyond ordinary use of the features we provide; or (e) use them in violation of law. All intellectual property rights in the Materials remain with Norte Regulatorio or its licensors. Public-source data remains subject to its original terms. As between you and us, you may use the drafts and work product you create with the Kit in your own work, and we claim no ownership of them. We may suspend or terminate your access if you materially breach these terms, without refund of fees for the period of breach, except where the law requires otherwise.
12. Subscriptions, Free Trials and Alerts
12.1 Plans and renewal. Paid plans (Individual, Team and Executive Watch) are billed in advance, monthly or yearly as shown at checkout, and renew automatically for the same period at the price shown at checkout until you cancel.
12.2 Free trial. New subscribers to a paid plan may receive a free trial, currently 10 days, as shown at checkout. A valid payment method is required. Unless you cancel before the trial ends, your payment method will be charged automatically for the first billing period on the date the trial ends, and then on each renewal date. We show the trial end date at checkout and in your confirmation email. One trial per person or organization. We may refuse or end a trial that is being abused.
12.3 Cancellation. You may cancel at any time, online, in the billing portal linked on the website and in every email, without contacting us. You may also cancel by emailing hola@norteregulatorio.com. If you cancel during the trial, you will not be charged. If you cancel after being charged, cancellation takes effect at the end of the current billing period and you keep access until then.
12.4 Confirmation and reminders. After you subscribe we will email you the terms of your subscription and how to cancel. We will send you a reminder before your free trial ends and before each annual renewal.
12.5 Price changes. We may change prices for future billing periods by giving you at least 15 days’ notice by email. The new price applies only from your next renewal after that notice, and you may cancel before then without being charged the new price. If you are a consumer in Mexico, Section 19.3 also applies.
12.6 Refunds. We do not refund partial periods or unused time, except where required by law (including consumer protection law) or where we agree in writing. If you believe you were charged in error, email us promptly and we will review it.
12.7 Changes to plans. We may improve or change features. If we discontinue a paid plan or materially reduce its paid features, we will notify you by email, you may cancel, and we will refund the unused portion of any prepaid period for a discontinued plan.
12.8 Company watchlist and alerts. Paid plans include email alerts about new public FDA recall records and warning letters that mention the companies on your watchlist, up to the number of companies stated for your plan. Alerts are checked periodically, not in real time, and are based on public sources that can be delayed, incomplete or revised. Matching depends on company names as FDA records them, so an alert may miss a record filed under a different name or include a related entity. Emails can be delayed, blocked or filtered by your provider. Alerts are a convenience. They are not a monitoring, surveillance or compliance service, and you must not rely on them as your only source.
13. One-Time Purchases, Prices, Taxes and Refunds
13.1 Digital delivery. The Kit and other one-time products are digital and delivered electronically immediately after payment. Because they are delivered immediately, one-time sales are final once delivered or accessed, except as stated in Section 13.2, where a refund or right of withdrawal is required by applicable law, or where we agree in writing.
13.2 Right of revocation for consumers. If you are a consumer under the Mexican Ley Federal de Protección al Consumidor (“LFPC”) and you buy a one-time digital product (such as the Kit) from us at a distance, you may revoke your purchase, without any liability, within five (5) business days counted from delivery (LFPC, art. 56). To revoke, email hola@norteregulatorio.com or use any other verifiable means. We will refund the price you paid through the original payment method. After you revoke, you must stop using the Kit and delete your copies. Under the same article, this right does not apply to services whose date of provision is ten business days or less after the order date, for example a subscription that starts immediately. If the law of another country gives you a similar right, you may exercise it in the same way.
13.3 Problems with delivery. If a download does not work, is not delivered, or the Kit is materially different from its description, email us and we will fix it or refund you.
13.4 Prices and taxes. Prices are set in U.S. dollars (USD). Where your payment method or location allows it, checkout may also show an approximate equivalent in your local currency, including Mexican pesos; the amount charged is the one shown at checkout. Applicable taxes (for example, IVA or sales tax) are calculated and shown at checkout where required. You are responsible for any fees or currency-conversion charges applied by your bank or card issuer, and for taxes on your own income. Payments are processed by Stripe; we do not store your full card details. Customers in Mexico may request a CFDI invoice by sending their tax data to hola@norteregulatorio.com.
14. Eligibility and Accounts
You must be at least 18 years old and have authority to accept these terms (including on behalf of any organization you represent). You are responsible for keeping your passwords and download links private and for activity under your account.
15. Third-Party Services, Links and Trademarks
The Services may rely on or link to third-party services (such as AI providers, data sources, hosting, email and payment platforms). We do not control and are not responsible for them. “Claude” is a trademark of Anthropic, PBC; “ISO” is a trademark of the International Organization for Standardization; “Excel” is a trademark of Microsoft Corporation; other names are trademarks of their owners. Norte Regulatorio is not affiliated with or endorsed by any of them. International standards such as ISO 13485 and ISO 14971 are cited by clause number only; obtain your own licensed copy.
16. Communications
You agree that we may communicate with you electronically (including by email) about your account, purchases, subscriptions and these terms. Newsletter emails include an unsubscribe link, and you may stop them at any time. Transactional emails (receipts, renewal and security notices) will continue while you have an active subscription or purchase.
17. Governing Law and Disputes
These terms are governed by the federal laws of the United Mexican States, without regard to conflict-of-law rules. Any dispute will be resolved exclusively in the competent courts of Ensenada, Baja California, Mexico, and you consent to that jurisdiction, except where mandatory consumer protection law gives you the right to bring a claim before another authority or court, including the Procuraduría Federal del Consumidor (PROFECO) or the courts of your domicile. If you are not a consumer, then to the extent permitted by law, claims must be brought individually and not as a class or representative action, and before filing a claim in court you agree to first contact us at hola@norteregulatorio.com and allow 30 days to resolve the issue informally. If you are a consumer, contacting us first is encouraged but is not required, and nothing in this Section limits your right to complain to any consumer or data-protection authority or to bring any action the law gives you.
18. General, Changes and Language
These terms are the entire agreement between you and us about the Services. If any provision is unenforceable, the rest remains in effect. Our failure to enforce a provision is not a waiver. Neither party is liable for delay or failure caused by events beyond its reasonable control. You may not assign these terms without our consent. We may assign these terms to a company we form or to a successor that assumes our obligations to you, upon notice published on the site. We may update these terms at any time; the version published on the site is the version in force. For changes that materially affect paid subscribers, we will give at least 15 days’ notice by email, and continued use after that period means you accept the update; you may cancel before then. Section 19.3 applies to consumers in Mexico. These terms are provided in English and Spanish. For consumers in Mexico, the Spanish version prevails if there is any conflict (see Section 19.1); in all other cases the English version prevails.
19. Consumers in Mexico
This Section applies if you are a consumer under the Mexican Ley Federal de Protección al Consumidor (“LFPC”) and prevails over any other provision of these terms.
19.1 Language. These terms are offered in Spanish, and the Spanish version is the one that governs your contract with us (LFPC, art. 85).
19.2 Liability. Sections 7, 8, 9 and 10 do not release us from civil liability that the law does not allow us to exclude, do not shift our civil liability to you or to any third party, and do not waive any protection the LFPC gives you. Section 10 does not apply to you.
19.3 Changes. We will not unilaterally modify the content of these terms or the price you agreed for the current billing period. Changes to terms or prices apply to you only if you accept them, for example by accepting the updated terms at checkout, or by continuing your subscription after we notify you at least 15 days in advance and give you the chance to cancel without being charged the new price.
19.4 Time limits and formalities. Nothing in these terms shortens the legal limitation periods or requires any formality to bring a claim against us. The informal contact step in Section 17 is optional for you.
19.5 Authorities and courts. You may take any complaint to PROFECO and to the competent Mexican courts. Nothing in these terms waives your rights under the LFPC or submits you to the courts of another country.
19.6 Revocation. See Section 13.2.
Contact: hola@norteregulatorio.com