Terms and Conditions

TNH CONSULTING LLC
TERMS AND CONDITIONS

Last Updated: September 25, 2025

Acceptance of Terms

By accessing and using the TNH Consulting LLC website (https://tnhconsulting.co) and services, you accept and agree to be bound by these Terms and Conditions. If you do not agree to these terms, please do not use our website or services.

Services Description

TNH Consulting LLC provides regulatory compliance consulting services including, but not limited to:

  • Risk Evaluation and Mitigation Strategies (REMS) consulting
  • Post-marketing Adverse Drug Experience (PADE) and pharmacovigilance compliance services
  • FDA inspection preparation and support
  • Root cause analysis and CAPA development
  • Regulatory training and education
  • Crisis response and regulatory guidance
  • Strategic regulatory planning and implementation

User Conduct and Responsibilities

Users of our website and services agree to:

  • Provide accurate and complete information in all communications
  • Use our services and website only for lawful purposes
  • Respect intellectual property rights and confidentiality obligations
  • Not attempt to gain unauthorized access to our systems or data
  • Not use our services to compete with TNH Consulting or develop competing services
  • Maintain the confidentiality of any proprietary methodologies or approaches shared

Client Responsibilities

Clients engaging our services are responsible for:

  • Providing accurate and complete information relevant to the engagement
  • Implementing recommendations appropriately and in compliance with applicable laws
  • Obtaining necessary internal approvals and legal review
  • Maintaining confidentiality of proprietary methodologies and work products
  • Complying with all applicable laws and regulations
  • Making final decisions regarding regulatory strategies and submissions

Website Availability and Technical Issues

While we strive to maintain continuous website availability, we do not guarantee:

  • Uninterrupted access to our website or online services
  • Error-free operation of website functions
  • Compatibility with all devices or browsers
  • Protection against all technical disruptions or cyber attacks

Our website may be temporarily unavailable due to maintenance, technical issues, or factors beyond our control.

Limitation of Liability

TNH Consulting LLC’s liability is limited to the fees paid for the specific services provided. We are not liable for:

  • Indirect, incidental, special, punitive, or consequential damages
  • Business interruption, loss of profits, or loss of data
  • Regulatory actions taken by government agencies
  • Client’s failure to implement recommendations appropriately
  • Results of regulatory submissions or agency decisions
  • Third-party actions or decisions

Intellectual Property Rights

Our Property: All materials, methodologies, work products, and content created by TNH Consulting LLC remain our intellectual property unless otherwise agreed in writing. This includes:

  • Proprietary assessment methodologies and frameworks
  • Training materials and educational content
  • Analytical tools and evaluation matrices
  • Website content and design elements

Client Property: We respect client intellectual property and will not use client confidential information except as necessary to provide contracted services.

Confidentiality and Non-Disclosure

TNH Consulting LLC maintains strict confidentiality regarding:

  • All client information and regulatory matters
  • Business strategies and competitive information
  • Regulatory submissions and agency communications
  • Internal business operations and financial information

Clients agree to maintain confidentiality regarding:

  • TNH Consulting LLC’s proprietary methodologies and approaches
  • Strategic recommendations and analytical frameworks
  • Internal business information and processes

Regulatory and Professional Disclaimers

No Legal Advice: Our services do not constitute legal advice. Clients should obtain independent legal counsel for legal matters related to regulatory compliance.

No Guarantee of Outcomes: We cannot guarantee FDA approval, regulatory compliance, or specific outcomes from agency interactions.

Advisory Services Only: Our services are advisory in nature. Final decisions regarding regulatory strategies and compliance remain solely with the client.

Dispute Resolution

Prior to pursuing litigation, parties agree to:

1. Written Notice: Provide 30 days written notice of any dispute

2. Good Faith Discussion: Attempt resolution through direct communication

3. Mediation: Participate in mediation with a mutually agreed mediator

If dispute resolution is unsuccessful, any legal proceedings must be conducted in New Jersey state or federal courts.

Governing Law

These terms are governed by the laws of the State of New Jersey, without regard to conflict of laws principles.

Modifications and Updates

TNH Consulting LLC reserves the right to modify these terms at any time. Material changes will be posted on our website with an updated effective date. Continued use of our services after changes become effective constitutes acceptance of modified terms.

Termination

We reserve the right to terminate or suspend access to our website or services for:

  • Violation of these terms of use
  • Fraudulent or abusive behavior
  • Legal or regulatory compliance requirements
  • Business operational reasons

External Links and Third-Party Content

Our website may contain links to external sites. TNH Consulting LLC is not responsible for:

  • Content or privacy practices of external websites
  • Accuracy or reliability of third-party information
  • Services or products offered by linked sites
  • Security of external website transactions

Copyright and Trademark Notice

The material on this website is protected by copyright and trademark laws. You may not:

  • Copy, reproduce, distribute, or publish content for commercial purposes
  • Create derivative works based on our content
  • Use our trademarks or service marks without permission
  • Distribute content over networks or social media platforms without authorization

For permission to use content, contact us at info@tnhconsulting.co.

Contact Information

For questions about these Terms of Use, contact us at:

Email:  info@tnhconsulting.co

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