Terms of Service

1Acceptance of these terms

By completing a purchase or using materials from Regulatory Options, you agree to be bound by these Terms. If you are buying on behalf of a company or other entity, you represent that you have authority to bind that entity. Where acceptance is collected at checkout (an “I Agree” step), your electronic acceptance is a legally binding signature under the Electronic Signatures in Global and National Commerce Act (E-SIGN) and the Washington Electronic Authentication Act, and a timestamped record of that acceptance is created and may be used as evidence of your agreement.

2Who we are

Regulatory Options, LLC is a Washington limited liability company. You can reach us at operations@regulatoryoptions.com.

3What we provide

Services. A written regulatory review or opinion on a document you send us, or a document we build for you from the records you provide. The deliverable is work product prepared for your internal compliance use.

Assessments. A read of the documents you send us against every requirement of one certification standard or regulation you select, returning the findings, a requirement-to-document map, a document cross-reference map, and a workbook. An assessment is a read of documents: no site visit is performed, requirements that turn on physical conditions or observed practice are named as outside the read, and no grade, pass, or audit outcome is predicted.

Training. Access to courses that teach a regulatory topic, for your and your team’s internal use.

Programs. Document-system bundles. These contain two tiers: Tier 1 working documents (procedures, forms, logs, checklists, and templates) that you may customize, edit, populate, and adapt to your operation; and Tier 2 protected materials (our branded guides, quick-start materials, knowledge checks, answer keys, and crosswalks) that you may use as provided but may not modify, rebrand, or turn into derivative works.

Subscriptions. Ongoing access to Regulatory Options, billed monthly, for the work described on the page for that subscription. Section 18 governs subscriptions and controls over any conflicting provision elsewhere in these Terms.

4No professional advice

Everything we provide is an educational and implementation resource. Nothing we provide is legal advice, regulatory advice, a compliance certification, an FDA or other agency determination, a certificate of analysis, a GMP audit, or a product release or disposition decision, and nothing we provide creates an attorney-client relationship. We are not a law firm and do not provide legal services. You should consult qualified legal counsel or regulatory professionals about your specific obligations. We make no representation that using our materials or services will satisfy any specific regulatory requirement, agency expectation, or certification standard as applied to your particular operation.

5Your rights to what you buy

Services. The deliverable we prepare for you is yours to use, keep, and rely on for your internal compliance program, subject to our underlying intellectual property in the methods, frameworks, and templates used to produce it.

Programs. We grant you a limited, non-exclusive, perpetual license to use the Program Materials for your internal compliance purposes, on the Tier 1 / Tier 2 terms in Section 3.

Training. We grant you a limited license to access and use course materials for your own and your team’s internal learning.

Assessments. The findings, maps and workbook we prepare for you are yours to use, keep, and rely on for your internal compliance program, on the same terms as a Service deliverable.

Subscriptions. Every answer, determination, conclusion, register, specification and record we produce for you under a subscription is yours. You may use, keep, rely on, retain and produce it to any regulator, certification body, auditor or customer without further permission from us, and that right survives the end of the subscription. Our underlying intellectual property in the methods, frameworks and templates used to produce it remains ours.

Any content you independently create or add while customizing Tier 1 materials is your own work product, and we make no claim to it.

6Our intellectual property

Except for what Section 5 gives you, all materials we create — templates, frameworks, written opinions and built deliverables as originally authored, case studies, training content, and the content of this website — are and remain the exclusive intellectual property of Regulatory Options, LLC. We claim nothing in the text of a statute, a regulation, or another body’s standard, whether we quote it or paraphrase it. What we sell you is a license or a delivered work product, not a transfer of ownership in our underlying intellectual property. We retain all copyright, trade dress, and other rights.

7Restrictions

You may share what you purchase with your own employees, contractors, agents, retained legal counsel, qualified individuals, auditors, and professional advisors in connection with your compliance program, and you may produce it to any regulator, certification body or customer entitled to see it. Where a deliverable carries a notice restricting its distribution, this Section governs and that notice is read subject to it. You may not: reproduce, distribute, sell, sublicense, rent, lease, or otherwise commercially exploit our materials; represent our materials as your own original work, or remove or obscure our intellectual-property notices or branding; use our materials to create competing products, templates, bundles, or services for sale or distribution; or post or distribute our materials publicly or to anyone outside your organization except as permitted above.

8Payment

Prices are as listed at the point of sale, in U.S. dollars. Payment is processed by our third-party payment processor; we do not store your full card details. Payment is what completes a purchase; the records needed for a service are collected separately after payment, through our intake process, and are not an on-site upload or a condition of checkout. Where a service is priced as a base plus optional add-ons, each item you select is charged accordingly.

Refunds. All purchases are final. Fees are non-refundable once we begin work on your order — for a service or an assessment, when you submit the records we request; for training and program purchases, immediately upon purchase, when access is delivered; for subscriptions, as set out in Section 18. If we determine we cannot perform a service or assessment you purchased, we refund the fee for it.

Chargebacks. Your acceptance of these Terms at checkout is recorded with a timestamp under Section 1. Where a payment is disputed with your card issuer or bank, we will answer the dispute with that record and with evidence of the access or work product delivered. Raising a dispute does not suspend your obligations under these Terms, and we may suspend access while a dispute is open.

Submitting your records. For services, after payment we send a request for the records we need to begin. You must submit them within 14 days of that request. If we do not receive them within 14 days, we may close the order and the fee is forfeited. We may reinstate a closed order at our discretion if you contact us.

9Versions and updates to materials

Your purchase covers the version of the materials available at the time of purchase. Materials are developed against the edition of the applicable regulatory standard in effect at the time of development. When a revised edition of a standard is released, any updated program or materials we develop are separate products and are not included in your original purchase. Help migrating an existing program to a new standard edition is available as a separate engagement.

10As is; no warranty

Our materials and services are provided “as is.” We make no warranties, express or implied, including any implied warranty of merchantability, fitness for a particular purpose, or regulatory-compliance outcome. Certification outcomes, audit results, and regulatory determinations depend on how you customize, implement, maintain, and operate your own compliance program. We do not guarantee any specific certification outcome, audit result, or regulatory determination.

11Indemnification

You agree to defend, indemnify, and hold harmless Regulatory Options, LLC and its owners, officers, agents, and successors from and against any and all claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys’ fees) arising out of or related to: (a) your use, misuse, customization, implementation, or distribution of our materials or services; (b) your failure to comply with applicable laws or regulations; (c) any regulatory action, inspection finding, or enforcement matter involving your compliance program; or (d) any breach of these Terms by you. This does not extend to any claim to the extent it arises from our own negligence, our own breach of these Terms, or an error in work we performed. We may assume exclusive control of any matter subject to indemnification, at your expense.

12Limitation of liability

To the maximum extent permitted by law, in no event will Regulatory Options be liable for any indirect, incidental, special, consequential, or punitive damages arising from or related to your use of our materials or services, even if advised of the possibility of such damages. Our total liability under these Terms will not exceed the amount you paid for the applicable product or service. For a subscription, that amount is the total of the subscription fees and any setup fee you paid us in the twelve months before the event giving rise to the claim.

13Governing law; disputes; attorneys’ fees

We sell to buyers in the United States. These Terms are governed by the laws of the State of Washington, without regard to its conflict-of-law provisions. Any dispute arising under or in connection with these Terms will be resolved in the state or federal courts located in Washington State, and both parties consent to the personal jurisdiction of those courts. In any such dispute, the prevailing party is entitled to recover its reasonable attorneys’ fees, court costs, and related expenses. Any claim arising out of or relating to these Terms must be brought within one year after the claim arose, or it is permanently barred, to the extent the law allows a period to be set by agreement. Each party waives any right to a jury trial. Claims are brought individually; neither party may bring a claim as a class, collective or representative action, or consolidate a claim with anyone else’s.

14Transferability

A license is granted to the purchasing entity. If that entity undergoes a change of ownership, acquisition, or merger, the license transfers to the successor entity without an additional purchase, provided the successor assumes and agrees to be bound by these Terms.

15Changes to these terms

We may update these Terms at our discretion. Updates apply to purchases made after the effective date of the updated terms; purchases completed before an update remain governed by the terms in effect at the time of purchase. The current version is always available on this website.

16Severability, waiver, entire agreement

If any provision of these Terms is found invalid or unenforceable, it will be modified to the minimum extent necessary to make it enforceable, or severed, and the remaining provisions continue in full force. Our failure to enforce any right is not a waiver of it. Sections 4, 5, 6, 7, 10, 11, 12, 13 and the confidentiality and record-return provisions of Section 18 continue in force after any purchase is completed and after any subscription ends. These Terms, together with the limitations and exclusions stated on the page for the product or subscription you bought, are the entire agreement between you and Regulatory Options regarding their subject matter and supersede prior agreements and understandings. Descriptive copy on that page tells you what a thing is; it does not create a warranty or a term. Where a page states a limitation on what a product or subscription does — that no site visit is performed, that nothing is independently verified, that a deadline is not accepted unless we confirm it in writing, that sending us something does not transfer responsibility for it, or that a conclusion holds only while the facts it rested on remain accurate — that limitation forms part of this agreement. Where a page and these Terms conflict, these Terms govern.

17Examples and constructed cases

All company, brand, product, and specimen names used in examples, worked cases, sample documents, and teaching materials on this website and in our materials are fictional and are used for illustration only. Any resemblance to a real company, product, brand, or trademark, whether existing or past, is coincidental. Nothing in these examples is intended to identify, endorse, or disparage any real person, company, product, or mark, and no affiliation with or association with any real entity is implied or intended.

18Subscriptions

What a subscription is. A subscription gives you ongoing access to Regulatory Options for the work described on the page for that subscription. The fee buys availability and the continuing relationship, not a set quantity of work, a number of requests, or a number of hours. Nothing is metered and nothing accrues. What the fee does assume is an operation of roughly the size you described at onboarding. If what you send us settles at a level that is plainly a different business from the one we priced, we tell you and agree a new fee before we carry on — we do not meter you, and we do not bill you for it afterwards.

Billing and renewal. Subscriptions are billed monthly in advance and renew automatically until you cancel. You may cancel at any time before your next renewal, which stops future billing. Cancellation does not refund the current month or any earlier month, and unused capacity does not carry forward, because the fee is earned by our availability during that month whether or not you use it.

Onboarding. Where a subscription carries a separate onboarding fee, that fee is earned when we issue the onboarding request and is non-refundable from that point, including where you do not return the information requested. The band you choose sets how many we establish at the outset. A smaller band costs less and establishes fewer at the start; the rest is worked through under the subscription, which is not limited by volume. We do not invoice a difference and we do not bill after the fact. Onboarding is priced from the size of the material to be established at the outset; the recurring fee does not vary with volume.

What a subscription covers, and what it does not. We determine whether a request is answered within your subscription or requires separate scope and pricing, and we tell you before beginning any work that falls outside it. What each subscription produces is listed on its page, and that is inside the fee. Anything beyond that list — an investigation, a system assessment, a formal response to an agency, or a document the subscription does not already produce — is scoped and priced before it starts.

How a subscription operates. Subscriptions run in writing and asynchronously, through the channel we designate, during our normal business operation. A subscription does not provide continuous monitoring of your operation, your records, your correspondence, your suppliers, or regulatory developments; it does not provide real-time, emergency, same-day, evening, or weekend availability; and it does not make us your quality unit, management representative, authorized agent, responsible person, or legal counsel. Submitting a question, document, notice, or deadline to us does not transfer responsibility for that matter to us, and no deadline of yours is accepted unless we confirm that acceptance in writing.

What our conclusions rest on. Every determination, conclusion, or recommendation issued under a subscription states what it was based on and the date it was made, and holds only for those facts. We are responsible only for information actually submitted through the channel we designate, and not for information withheld, omitted, inaccurate, or changed after we relied on it. You remain responsible for your own compliance, decisions, approvals, implementation, submissions, and deadlines.

Cancelling. You may cancel at any time, effective at the end of the billing month in which you cancel, by whatever means you signed up through, or by emailing us. Cancelling is no harder than subscribing was: no reason is required, no notice period applies, nobody will call you, and you will not be asked to complete a form or speak to anyone first. We act on a cancellation within one business day and confirm it in writing. Cancellation stops all future billing and does not refund the current or any earlier month.

Ending a subscription. Access ends when the subscription ends. Deliverables already issued to you remain yours under Section 5. We may end a subscription on 30 days’ notice, or immediately where a request would require work we cannot competently or ethically perform, creates a conflict, or breaches these Terms.

Your own records. Everything we produce for you is delivered to you as it is produced and is yours to keep from that moment. We are not your record keeper. Keeping your own records, retaining them, and being able to produce them when someone asks remains yours, and nothing in a subscription changes that. We keep our own copy of what we produced and what it rested on for two years after a subscription ends, and longer once either of us has told the other that a claim or an inquiry is coming.

Confidentiality. We treat everything you send us, everything we produce for you, and the fact and content of your engagement as confidential. We do not disclose it to anyone outside Regulatory Options except where you direct us to, to the service providers we use to run the business and who are bound to keep it confidential, or where a law or a court compels it — and where we are compelled we tell you first unless we are forbidden to. This obligation continues after the subscription ends and is not limited in time. It does not cover information that is public through no act of ours, that you tell us is not confidential, or that we held before you sent it.

19Contact

Questions about these Terms: operations@regulatoryoptions.com.