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.

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.

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.

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

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. 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. 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, when you submit the records we request; for training and program purchases, immediately upon purchase, when access is delivered. If we determine we cannot perform a service you purchased, we refund the fee for that service.

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. 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.

13Governing law; disputes; attorneys’ fees

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.

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. These Terms are the entire agreement between you and Regulatory Options regarding their subject matter and supersede prior agreements and understandings.

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.

18Contact

Questions about these Terms: operations@regulatoryoptions.com.