Terms of Service

Last Updated: 08/13/2026

Welcome to KKW Regulatory Solutions LLC (“KKW,” “we,” “us,” or “our”). These Terms of Service (“Terms”) govern your access to and use of our website located at kkwregulatorysolutions.com (the “Site”), including any content, functionality, and services offered on or through the Site.

By accessing or using the Site, you agree to be bound by these Terms. If you do not agree to these Terms, please do not use the Site.

1. About KKW Regulatory Solutions

KKW Regulatory Solutions LLC provides boutique regulatory affairs consulting services for pharmaceutical and biotech companies, start-ups, and investigator-initiated studies, including but not limited to Initial Clinical Trial Application (IND) support, NDA/BLA submission support, clinical study report compilation, post-approval submission support, vendor oversight, and regulatory project management (“Services”).

This Site is intended to provide general information about KKW and its Services. Any actual engagement for consulting Services is governed by a separate written agreement (a “Services Agreement” or “Statement of Work”) executed between KKW and the client. These Terms apply to your use of the Site itself and do not constitute a Services Agreement.

2. Eligibility

By using this Site, you represent that you are at least 18 years of age and are accessing the Site on behalf of yourself or an organization you are authorized to represent.

3. Use of the Site

You agree to use the Site only for lawful purposes and in accordance with these Terms. You agree not to:

Use the Site in any way that violates any applicable federal, state, local, or international law or regulation.
Attempt to gain unauthorized access to any portion of the Site, other accounts, computer systems, or networks connected to the Site.
Use any automated means, including bots, scrapers, or spiders, to access the Site for any purpose without our prior written consent.
Interfere with or disrupt the operation of the Site or servers or networks used to make the Site available.
Transmit any material that contains viruses, malware, or other harmful computer code.
Impersonate or attempt to impersonate KKW, a KKW employee, or any other person or entity.

4. Intellectual Property Rights

The Site and all content, features, and functionality (including but not limited to text, graphics, logos, images, and the KKW name and branding) are owned by KKW Regulatory Solutions LLC or its licensors and are protected by United States and international copyright, trademark, and other intellectual property laws.

You may view, download, and print content from the Site for your own personal, non-commercial use, provided you do not modify the content and you retain all copyright and proprietary notices. You may not reproduce, distribute, publicly display, or create derivative works from any content on the Site without our prior written consent.

5. No Professional or Regulatory Advice via the Site

The content on this Site — including service descriptions, FAQs, and general information about regulatory processes — is provided for general informational purposes only and does not constitute regulatory, legal, medical, or professional advice. Use of the Site or submission of an inquiry through the Site does not create a client relationship, consulting relationship, or any other professional relationship between you and KKW. A professional relationship is formed only upon execution of a written Services Agreement.

You should not rely on general information provided on the Site as a substitute for consultation with KKW or another qualified professional regarding your specific regulatory circumstances.

6. Third-Party Links and Scheduling Tools

The Site may contain links to third-party websites or services, such as scheduling tools used to book a discovery call, or references to client, partner, or affiliate organizations. These links are provided for your convenience. KKW does not control and is not responsible for the content, privacy practices, or availability of any third-party sites or services. Your use of any third-party site or tool is subject to that third party’s own terms and privacy policy.

7. Submitted Information

Any information you submit through the Site (for example, via the contact form) will be used by KKW to respond to your inquiry and, where applicable, to evaluate a potential engagement. See our [Privacy Policy] for details on how we collect, use, and protect information submitted through the Site.

You agree not to submit any information through the Site that is false, misleading, or that you do not have the right to disclose, including confidential information belonging to a third party without authorization.

8. Disclaimers

THE SITE AND ALL CONTENT ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS, WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR THAT THE SITE WILL BE UNINTERRUPTED, SECURE, OR ERROR-FREE.

KKW does not warrant that the results obtainable from any consulting engagement will meet your expectations or that any regulatory submission or application will be approved by any regulatory authority. Regulatory outcomes depend on numerous factors outside of KKW’s control, including the decisions of applicable regulatory agencies.

9. Limitation of Liability

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL KKW REGULATORY SOLUTIONS LLC, ITS OWNERS, EMPLOYEES, OR AGENTS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS OR REVENUES, ARISING OUT OF OR RELATED TO YOUR USE OF, OR INABILITY TO USE, THE SITE, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR ANY OTHER LEGAL THEORY, EVEN IF KKW HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Nothing in these Terms limits or excludes liability that cannot be limited or excluded under applicable law. Any liability arising from an actual Services Agreement will be governed by the terms of that agreement, not these Terms.

10. Indemnification

You agree to indemnify, defend, and hold harmless KKW Regulatory Solutions LLC and its owners, employees, and agents from and against any claims, liabilities, damages, losses, and expenses, including reasonable attorneys’ fees, arising out of or in any way connected with your violation of these Terms or your misuse of the Site.

11. Changes to These Terms

We may revise and update these Terms from time to time at our sole discretion. All changes are effective immediately when posted and apply to all access to and use of the Site thereafter. Your continued use of the Site following the posting of revised Terms means you accept and agree to the changes. We encourage you to review these Terms periodically.

12. Governing Law

These Terms and any dispute arising out of or related to them or the Site shall be governed by and construed in accordance with the laws of the State of [Insert State], without regard to its conflict of law provisions.

13. Severability

If any provision of these Terms is found to be unlawful, void, or unenforceable, that provision shall be deemed severable from these Terms and shall not affect the validity and enforceability of the remaining provisions.

14. Contact Us

If you have questions about these Terms, please contact us at:

KKW Regulatory Solutions LLC Email: kevin@kkwregulatorysolutions.com Based in the United States · Remote engagements globally