Terms of Service

1. Acceptance of these Terms

These Terms of Service (the “Terms”) are a legally binding agreement between you and Precision Regulatory Consulting LLC, a North Carolina limited liability company (“PRC,” “we,” “us,” or “our”). They apply when you visit precisionregulatory.com, create an account, purchase or use a membership, access the customer portal, register for a program, download a resource, use an interactive or AI-assisted tool, or otherwise use any service that links to these Terms (collectively, the “Services”).

By accessing or using the Services, clicking a button that indicates acceptance, creating an account, or completing a purchase, you acknowledge that you have read, understood, and agreed to these Terms and our Privacy Notice. If you do not agree, do not create an account, make a purchase, or use the Services.

If a product page, checkout page, order form, statement of work, master services agreement, enterprise agreement, or other written agreement signed by PRC contains terms that conflict with these Terms, the more specific signed agreement controls for that particular engagement. These Terms continue to govern use of the public website and any matters not addressed in the signed agreement.

2. Eligibility and authority

You must be at least 18 years old and legally capable of entering a binding contract to use a paid Service. If you use the Services for a company, university, government agency, nonprofit organization, or other entity, you represent that you are authorized to accept these Terms on that entity’s behalf. In that situation, “you” includes both you and the entity.

You may not use the Services if applicable law prohibits you from doing so, if PRC previously suspended or terminated your access for material misuse, or if you are located in a jurisdiction where providing the Services would violate applicable trade or sanctions laws.

3. The Services

PRC provides regulatory and quality-system information, professional education, membership content, courses, workshops, webinars, templates, checklists, guides, simulations, and AI-assisted workflow tools. Some resources are public, some are available through a free account, and others require a paid Premium, Elite, enterprise, event-specific, or product-specific purchase.

Descriptions, schedules, instructors, learning objectives, formats, included materials, access periods, and prices appear on the relevant product or checkout page. We may improve, replace, reorganize, or retire content as regulatory requirements, technology, and professional practice evolve. A membership provides access to the resources included in that membership at the time of use; it does not transfer ownership of the Services or guarantee that every resource will remain available indefinitely.

4. Account registration and security

You agree to provide accurate, current, and complete registration and billing information and to keep it updated. You are responsible for protecting your username, password, authentication methods, and account-recovery information. Do not share your password or permit another person to use an individual account.

You are responsible for activity that occurs through your account to the extent permitted by law. Notify us promptly at info@precisionregulatory.com if you believe your account has been compromised, accessed without authorization, or used improperly. We may require email verification, password reset, multi-factor authentication, or additional identity or business verification when reasonably necessary to protect users, PRC, or the Services.

We may reject or remove usernames that impersonate another person or organization, infringe rights, contain misleading information, or create a security risk. Account approval, where required, is at PRC’s reasonable discretion.

5. Membership levels and access

Membership benefits depend on the level selected at checkout. These may include Free Preview, Premium, Elite, enterprise, or other plans introduced later. The applicable product page and checkout screen identify the price, billing frequency, included content, and any stated access period.

Unless a team or enterprise plan expressly permits multiple users, each membership is licensed to one named individual. You may not share login credentials, pool access, rotate one account among multiple people, or allow nonmembers to use restricted content. Organizations that need access for multiple personnel must purchase the appropriate number of seats or enter a written enterprise agreement with PRC.

Changing to another membership level may change your fees, access rights, renewal date, and available content. Downgrading or cancellation may remove access to restricted resources at the end of the applicable paid period. Downloaded materials remain subject to the license and restrictions in these Terms after membership ends.

6. Fees, payment, and taxes

Prices are shown before purchase. Unless stated otherwise, prices are in U.S. dollars and exclude applicable sales, use, value-added, withholding, or similar taxes. You are responsible for taxes that the law requires to be collected from or paid by you, except taxes based on PRC’s net income.

Payments may be processed by Stripe or another authorized payment provider. PRC does not receive or store your full payment-card number when payment is handled by the provider. By submitting a payment method, you represent that you are authorized to use it and authorize PRC and its payment provider to charge the displayed amount, applicable taxes, and any recurring charges you expressly accept.

If a payment fails, is declined, expires, or is reversed, we may retry the charge as permitted by the payment provider, ask you to update your payment method, restrict access, or suspend the affected subscription. You remain responsible for valid charges incurred before cancellation. If you believe a charge is incorrect, contact us promptly so we can investigate without limiting any non-waivable rights you may have with your financial institution.

7. Automatic renewal

Paid recurring memberships automatically renew until canceled. The checkout page will identify whether a plan renews monthly, annually, or at another stated interval, the amount due at enrollment, and the recurring price. By completing the purchase, you expressly authorize PRC and its payment provider to charge the payment method on file at each renewal interval until you cancel.

If we change the recurring price, billing interval, or another material renewal term, we will provide notice as required by applicable law before the change takes effect. If applicable law requires renewed consent, we will request it. Promotional pricing ends according to the terms displayed with the promotion.

You are responsible for keeping your email address and payment method current so that you can receive billing, renewal, payment-failure, and cancellation communications.

8. Cancellation

You may cancel a recurring membership through the cancellation controls in your Membership Account page or by emailing info@precisionregulatory.com from the email address associated with your account. Include the account holder’s name and membership level. We may ask for reasonable verification before changing an account.

Unless the checkout page states otherwise, cancellation stops future renewals and takes effect at the end of the current paid billing period. You may continue using the included Services until that date. Deleting an account, abandoning the Services, removing a payment method, or disputing a charge does not by itself cancel a subscription. Keep the cancellation confirmation for your records.

If you experience difficulty canceling online, contact us. We will not require you to provide a reason as a condition of cancellation. Any cancellation right that applicable law gives you remains available.

9. Refunds and credits

Initial membership purchase. Unless a product page states a different policy, you may request cancellation and a refund of your first Premium or Elite membership payment within seven calendar days after the initial purchase. If approved, access to paid content will end when the refund is processed.

Renewals. Renewal payments are generally nonrefundable, and we do not provide prorated refunds or credits for an unused portion of a billing period after cancellation. Cancel before the renewal date to avoid the next charge.

Digital products. Standalone templates, downloads, recordings, tool credits, and other digital products made available immediately are final sale after delivery or access, except for duplicate charges, an incorrect amount, a material technical failure that PRC cannot reasonably correct, or when applicable law requires otherwise.

Billing errors. Contact us promptly about duplicate charges, incorrect amounts, or a charge processed after a confirmed cancellation. We will investigate and correct verified errors. Refunds are returned to the original payment method when reasonably possible. Processing times are controlled partly by the payment provider and financial institution.

Nothing in this section limits refund, withdrawal, or cancellation rights that cannot legally be waived. Where applicable law conditions immediate access to digital content on express consent or acknowledgment, the checkout process may request that consent.

10. Live programs, workshops, and events

Live workshops, office hours, cohort programs, webinars, and consulting-adjacent events may have additional registration, attendance, cancellation, substitution, recording, confidentiality, and conduct terms displayed on the event page or order form. Those specific terms control for that event.

PRC may reschedule, change the delivery platform or instructor, or cancel an event for low enrollment, instructor unavailability, technical disruption, safety concerns, force majeure, or another reasonable business need. If PRC cancels a separately paid event and does not provide a reasonable replacement, we will offer a transfer, credit, or refund of the event fee. PRC is not responsible for travel, lodging, lost work time, or other indirect costs unless a signed agreement says otherwise.

Unless PRC expressly authorizes it in writing, participants may not record, livestream, transcribe for redistribution, or publicly share live sessions or participant discussions.

11. Training and educational content

PRC training, templates, checklists, simulation and AI-assisted tools are educational in nature. They do not provide legal advice; medical advice; an accredited certification to perform audits or inspections; a regulatory submission; an independent audit; an official compliance determination; nor do they provide a guarantee that a sponsor’s/manufacturer’s products will receive Health Authority clearance/approval/certification, pass inspection(s), or receive market access. / All inspection results or market access for sponsors/manufacturers and other responsible organizations remain accountable for their regulatory decisions, product safety, quality systems, records, submissions, reporting obligations and use of professional judgment.

Completion of a course or assessment shows participation or completion only, unless the program page expressly states otherwise. It does not establish licensure, board certification, regulatory authority, or guaranteed competence. Continuing-education credit is available only when expressly identified and subject to the requirements of the named accrediting body.

Sponsors/manufacturers and other responsible organizations remain fully accountable for their own regulatory actions and determinations; the safety of their products; the development and implementation of their quality system; maintenance of all appropriate records; timely completion of required submissions; meeting their reporting obligations; and using good professional judgement.

12. No regulatory, legal, medical, or clinical advice; no guaranteed outcome

The Services provide general regulatory, quality-system, and professional education. They do not provide legal advice, medical advice, clinical advice, tax advice, investment advice, or an opinion from FDA, a notified body, a competent authority, a standards organization, an accreditation body, or any other regulator.

No content, template, simulation, example, response, score, recommendation, or tool output guarantees FDA clearance or approval, acceptance of a filing, conformity assessment, certification, reimbursement, successful inspection, absence of observations, market access, or any other regulatory or commercial result. Outcomes depend on product-specific facts, evidence quality, regulatory classification, agency judgment, applicable law, and many factors outside PRC’s control.

You remain responsible for decisions, submissions, quality records, safety evaluations, clinical and technical evidence, labeling, claims, and communications with authorities. Use qualified legal counsel, regulatory professionals, clinicians, engineers, cybersecurity specialists, privacy professionals, and other experts when the circumstances require them.

13. AI-assisted tools

Some Services may use artificial intelligence or third-party models to organize information, generate drafts, identify possible gaps, simulate questions, or support a workflow. These tools are assistive. They do not replace qualified human judgment.

AI-assisted output may be incomplete, outdated, inconsistent, or incorrect. It may misunderstand context, omit controlling requirements, or facts. Users must independently review and validate all outputs. AI output must not be inserted directly into a submission, QMS record, investigation, CAPA, audit response or regulatory communication without qualified human review.

You may not represent raw tool output as an official PRC opinion, an agency determination, or independently verified evidence.

Do not enter Protected Health Information, patient-identifiable data, special-category personal data, trade secrets, unpublished inventions, security credentials, export-controlled information, or client-confidential material into a general AI tool found in the site.

14. No PHI or confidential submissions through public or general portal features

PRC’s public website, contact forms, ordinary account fields, training exercises, general membership portal, and general AI-assisted tools are not designed to receive Protected Health Information (PHI) or other patient-identifiable information. Do not submit PHI through these features.

Making the Services available does not by itself make PRC your HIPAA Business Associate or create a business-associate relationship. If a proposed consulting engagement may involve PHI, PRC and the client must first determine the applicable legal, contractual, privacy, and security requirements and execute any required written agreement, including a business associate agreement when legally appropriate, before information is transferred.

Public forms and general portal features are not a substitute for a secure client data room. Do not submit confidential, proprietary, patient-identifiable or regulated information through public forms or general portal features. Confidentiality obligations for consulting work apply only as stated in a signed NDA, MSA, SOW or other written agreement.

If you submit restricted information contrary to these instructions, you do so without authorization. Contact PRC promptly so we can assess reasonable next steps; however, we cannot guarantee that unauthorized transmission can be recalled or eliminated from every system or provider.

15. License to use courses, templates, and downloadable materials

Subject to payment of applicable fees and compliance with these Terms, PRC grants the authorized user a limited, revocable, nonexclusive, nontransferable, and nonsublicensable license to access and use the purchased or membership-included materials for the user’s personal professional development and internal business purposes during the applicable access period.

You may download or print materials only when the Service provides a download or print function. You may adapt an authorized template for your own organization’s internal use, but you may not remove proprietary notices, claim PRC materials as your original product, sell or license them, publish them to a shared repository, distribute them outside the authorized organization, or use them to create a competing course, template library, membership, database, or software product.

Unless an enterprise agreement says otherwise, the license does not permit company-wide distribution. Sharing a completed internal work product does not authorize sharing the underlying PRC training, instructions, source files, answer keys, videos, tool logic, or template library.

16. Acceptable use

You agree not to misuse the Services. Prohibited conduct includes:

• sharing accounts, bypassing membership controls, or accessing content you did not purchase or receive permission to use;
• copying, scraping, crawling, indexing, harvesting, bulk downloading, or systematically extracting content except through ordinary features provided to you;
• using PRC content or outputs to train, fine-tune, benchmark, or populate another artificial-intelligence model, dataset, or competing knowledge base without written permission;
• reverse engineering, probing, decompiling, or attempting to discover source code, prompts, system instructions, security controls, or nonpublic tool logic;
• uploading malware, malicious code, unlawful content, or information you do not have the right to provide;
• interfering with the website, authentication, payment processing, rate limits, logging, monitoring, or another user’s access;
• impersonating another person or organization or misrepresenting affiliation, authorization, credentials, or results;
• using the Services to violate privacy, intellectual-property, export-control, consumer-protection, employment, discrimination, or other applicable laws; or
• using PRC’s name, marks, instructor identity, or materials to imply endorsement, certification, agency affiliation, or a guaranteed regulatory result.

Reasonable assistive technologies, ordinary search-engine indexing of public pages, and use expressly authorized by PRC are not prohibited by this section.

17. User submissions and feedback

You retain ownership of content you lawfully submit to the Services. You grant PRC a limited, worldwide, nonexclusive license to host, process, transmit, reproduce, and display that content only as reasonably necessary to provide, secure, support, and improve the requested Service, comply with law, and enforce these Terms. Our handling of personal information is described in the Privacy Notice and any applicable written client agreement.

You represent that you have the rights and permissions necessary to submit the content and that doing so does not violate law, contract, confidentiality, privacy, or intellectual-property rights. You are responsible for keeping your own copies of important content.

If you voluntarily provide ideas or general feedback about the Services, you permit PRC to use that feedback without restriction or compensation, provided PRC does not publicly identify you or disclose your confidential information without permission.

18. Consulting engagements are governed separately

A consulting engagement begins only when PRC and the client execute an applicable written agreement, such as a master services agreement, statement of work, proposal accepted as a contract, or other engagement document. That agreement defines scope, deliverables, assumptions, responsibilities, fees, confidentiality, information security, intellectual-property rights, reliance, and liability for the consulting engagement.

Purchasing a membership does not include individualized consulting, review of a regulatory submission, legal advice, official sign-off, or priority support unless the applicable offer expressly includes it. Accessing the website, creating an account, purchasing training, submitting a form or communicating informally with PRC does not create a consulting relationship. Consulting services begin only after the parties execute the applicable written agreements. If a consulting agreement conflicts with these website terms concerning the engagement, the signed consulting agreement controls the services provides.

19. Third-party services and links

The Services may link to or interoperate with third-party services, including payment processors, hosting providers, video platforms, scheduling tools, email providers, analytics services, authentication services, regulatory websites, standards organizations, and AI providers. Third-party services are governed by their own terms and privacy practices.

Links are provided for convenience and do not necessarily mean that PRC endorses, controls, or guarantees the third party, its content, or its continued availability. PRC is not responsible for changes, outages, security incidents, data practices, prices, or content controlled by a third party, except to the extent applicable law provides otherwise.

20. Privacy and security

Our Privacy Notice explains what personal information we collect, why we use it, how we share it, how long we retain it, and the choices or rights that may apply. By using the Services, you acknowledge those practices.

We use administrative, technical, and organizational safeguards appropriate to the nature of the information and the Services we provide. No website, account, transmission method, storage system, or security control can eliminate all risk. You are responsible for using a secure device and network, protecting credentials, applying available updates, and promptly reporting suspected account compromise.

21. Suspension and termination

You may stop using the Services at any time, subject to the billing and cancellation provisions above. PRC may restrict, suspend, or terminate access when reasonably necessary because of nonpayment, account compromise, material breach of these Terms, infringement, unlawful conduct, misuse of restricted content, threats to users or systems, a legal request, or discontinuation of a Service.

When circumstances reasonably permit, we will provide notice and an opportunity to correct a remediable issue. Immediate action may be necessary for fraud, security threats, unlawful conduct, repeated violations, or material harm. Suspension or termination does not erase valid payment obligations incurred before the effective date.

Sections concerning intellectual property, licenses and restrictions, payment obligations, disclaimers, liability, indemnification, disputes, and general legal terms survive termination to the extent their nature requires.

22. Availability and changes to the Services

We aim to provide reliable access but do not promise uninterrupted or error-free operation. Maintenance, updates, hosting or network failures, cyber incidents, third-party outages, emergencies, and events beyond reasonable control may interrupt availability.

We may update, correct, replace, reorganize, or discontinue features or content. If we discontinue a material paid Service during a prepaid access period, we will use reasonable efforts to provide a substantially similar replacement, continued access for a reasonable transition period, or an appropriate credit or refund for the unavailable portion, depending on the circumstances and applicable law.

23. Intellectual property and infringement notices

The Services and their original content, course structure, videos, text, graphics, photographs, branding, trademarks, templates, downloads, tool interfaces, compilations, software, and other materials are owned by PRC or its licensors and are protected by applicable copyright, trademark, trade-secret, and other intellectual-property laws. No right is granted except the limited license expressly stated in these Terms.

“Precision Regulatory,” associated logos, and related branding may not be used in a way that suggests endorsement, affiliation, certification, or sponsorship without written permission.

If you believe content available through the Services infringes your copyright or other intellectual-property rights, email info@precisionregulatory.com with your contact information, identification of the protected work, identification and location of the material at issue, the basis for your claim, and a statement that the information you provide is accurate and submitted in good faith. We may request additional information needed to evaluate the notice.

24. Disclaimer of warranties

To the maximum extent permitted by law, the Services are provided “as is” and “as available.” PRC disclaims implied warranties of merchantability, fitness for a particular purpose, title, noninfringement, and any warranty arising from course of dealing or usage of trade.

PRC does not warrant that the Services will be uninterrupted, error-free, completely secure, current in every jurisdiction, compatible with every system, or suitable for every regulatory program. PRC does not warrant that use of a template, tool, course, simulation, or recommendation will produce a particular regulatory, quality, legal, clinical, technical, or commercial result.

Some jurisdictions do not allow certain warranty exclusions. In those jurisdictions, exclusions apply only to the extent permitted by law.

25. Limitation of liability

To the maximum extent permitted by law, PRC and its owners, officers, employees, contractors, instructors, licensors, and service providers will not be liable for indirect, incidental, special, exemplary, punitive, or consequential damages; loss of profits, revenue, data, goodwill, business opportunity, or anticipated savings; regulatory delay; business interruption; or the cost of substitute services arising from or related to the Services, even if advised that such damages were possible.

To the maximum extent permitted by law, PRC’s aggregate liability arising from or related to the Services will not exceed the greater of (a) the amount you paid PRC for the specific Service giving rise to the claim during the twelve months before the event giving rise to liability or (b) one hundred U.S. dollars (US $100) if you used only free Services.

These limitations do not exclude liability that cannot lawfully be excluded or limited, including liability for PRC’s fraud, willful misconduct, or gross negligence where applicable law prohibits limitation. The limitations apply to the allocation of risk reflected in the price and are an essential basis of the agreement.

26. Indemnification

To the extent permitted by law, you agree to defend, indemnify, and hold harmless PRC and its owners, officers, employees, contractors, and licensors from third-party claims, damages, judgments, losses, liabilities, costs, and reasonable attorneys’ fees arising from: (a) your unlawful or unauthorized use of the Services; (b) content you submit without sufficient rights or permissions; (c) your material violation of these Terms; or (d) your infringement or violation of another person’s rights.

PRC will provide reasonable notice of a covered claim and reasonable cooperation at your expense. You may not settle a claim in a manner that admits fault by PRC, imposes obligations on PRC, or restricts PRC’s operations without PRC’s written consent. This section does not require you to indemnify PRC for PRC’s own fraud, willful misconduct, or gross negligence.

27. Governing law and disputes

These Terms are governed by the laws of the State of North Carolina, United States, without regard to conflict-of-laws rules, except that applicable federal law and non-waivable rights under the law of your place of residence continue to apply.

Before filing a lawsuit concerning these Terms or the Services, the complaining party will send a written notice describing the dispute and requested resolution. The parties will make a good-faith effort to resolve the dispute informally for at least thirty days after receipt of the notice. Notices to PRC must be sent to info@precisionregulatory.com with the subject “Legal Dispute Notice.” This informal process does not prevent either party from seeking urgent injunctive relief or filing within a limitations period.

If informal resolution is unsuccessful, the parties consent to the personal jurisdiction of courts of competent jurisdiction located in North Carolina, unless applicable law requires another forum. Nothing in these Terms prevents either party from bringing an eligible matter in small-claims court.

28. International use and trade controls

PRC is based in the United States and serves users in multiple jurisdictions. You are responsible for determining whether your use of the Services complies with laws applicable to you. PRC does not represent that every Service is appropriate for every country, product type, or regulatory system.

You may not access, export, re-export, transfer, or use the Services in violation of U.S. export-control, sanctions, or trade laws or other applicable restrictions. You represent that you are not prohibited from receiving the Services under applicable sanctions or restricted-party rules.

29. Changes to these Terms

We may update these Terms to reflect changes in the Services, law, security practices, payment practices, or business operations. The “Last updated” date identifies the latest revision.

For changes that materially affect an existing paid membership, we will provide reasonable advance notice through email, the account area, or a prominent website notice when required by law. Changes apply prospectively from their stated effective date. If you do not agree to a material change, you may stop using the Services and cancel a recurring membership before the change takes effect. Changes to these Terms do not retroactively alter a separately signed agreement.

30. General legal terms

Entire agreement. These Terms, the Privacy Notice, the applicable product and checkout terms, and any signed agreement constitute the complete agreement concerning the matters they cover and replace earlier discussions or statements about those matters.

Severability. If a provision is held unenforceable, it will be modified only as much as necessary to make it enforceable, and the remaining provisions will remain in effect.

No waiver. A failure or delay in enforcing a provision is not a waiver. A waiver must be in writing and applies only to the specific instance stated.

Assignment. You may not assign or transfer these Terms or an account without PRC’s written consent. PRC may assign these Terms in connection with a merger, acquisition, reorganization, sale of assets, or transfer to an affiliate, subject to applicable law.

No third-party beneficiaries. Except for parties expressly protected by the warranty, liability, or indemnification provisions, these Terms do not create rights for a person who is not a party to them.

Electronic communications. You consent to receive transactional notices electronically, including account, security, purchase, renewal, cancellation, and legal notices. Marketing communications are governed by applicable law and the choices described in the Privacy Notice.

Headings. Headings are provided for readability and do not limit the meaning of a provision.

Force majeure. Neither party is responsible for delay or failure caused by events beyond its reasonable control, except that this does not excuse payment obligations already incurred.

31. Contact us

Questions about these Terms, billing, cancellation, account access, or the Services may be sent to:

Please do not send PHI, patient-identifiable information, passwords, payment-card numbers, trade secrets, or confidential product information through ordinary email.