Terms of Service & Disclaimer

1. Scope of Services

All services provided are strictly educational and advisory in nature. Services may include mock inspections, regulatory assessments, compliance training, document review, gap analysis, and quality system consulting.

We do not manufacture, design, test, validate, certify, import, export, distribute, label, relabel, hold, release, or approve any regulated product in any jurisdiction. We do not act as a legal manufacturer, specification developer, marketing authorization holder, initial importer, authorized representative, responsible person, sponsor, or regulatory agent.

2. No Guarantee of Regulatory Outcome

No representations or guarantees are made regarding inspection outcomes, regulatory approvals, clearances, certifications, registrations, enforcement discretion, warning letter avoidance, import status, or compliance determinations. Regulatory decisions are made solely by governmental authorities.

3. Client Responsibility

  • The client retains sole, exclusive, and non-delegable responsibility for:
  • Compliance with all applicable laws and regulations worldwide.
  • Product design, manufacturing, validation, testing, labeling, distribution, and post-market activities.
  • Regulatory submissions and communications with authorities.
  • Implementation and maintenance of the quality management system.
  • All business and regulatory decisions made.

4. Zero Liability and Limitation of Damages

To the maximum extent permitted by applicable law worldwide, all liability arising from or related to services provided is expressly disclaimed.

  • Under no circumstances shall liability arise for:
  • Regulatory enforcement actions, including warning letters, recalls, seizures, injunctions, import alerts, consent decrees, or penalties.
  • Business interruption or operational disruption.
  • Loss of profits, contracts, goodwill, data, or revenue.
  • Indirect, incidental, consequential, exemplary, special, or punitive damages.

If liability is determined notwithstanding this limitation, total aggregate liability shall not exceed the total fees actually paid for the specific engagement giving rise to the claim.

5. Indemnification

The client agrees to defend, indemnify, and hold harmless the consultant, its officers, employees, contractors, and affiliates from and against any and all claims, demands, actions, damages, liabilities, losses, costs, and expenses, including reasonable attorneys’ fees, arising from:

  • The client’s regulatory activities.
  • The manufacture, distribution, or use of any product.
  • Implementation or non-implementation of recommendations.
  • Regulatory enforcement actions involving the client.

6. No Legal Representation

No legal advice is provided. No attorney-client relationship is created. Clients are responsible for obtaining independent legal counsel where necessary.

7. Mandatory Arbitration

Any dispute, claim, or controversy arising out of or relating to services provided shall be resolved exclusively by binding arbitration in the State of California under applicable arbitration rules. The arbitration shall be conducted by a single arbitrator. Judgment on the award may be entered in any court of competent jurisdiction.

The parties waive any right to jury trial and waive participation in class or collective actions.

8. Governing Law and Venue

These terms shall be governed by and construed in accordance with the laws of the State of California, without regard to conflict-of-law principles.

9. Force Majeure

No liability shall arise for delay or failure to perform resulting from causes beyond reasonable control, including acts of government, regulatory changes, natural disasters, labor disputes, cyber incidents, pandemics, transportation disruptions, or other force majeure events.

10. International Applicability

These terms apply globally to all services provided to entities operating within the United States and internationally. Regulatory compliance obligations remain solely with the client regardless of jurisdiction.

11. Severability

If any provision of these terms is found unenforceable, the remaining provisions shall remain in full force and effect.

12. Acceptance of Terms

Use of the website or engagement of services constitutes acknowledgment and acceptance of these terms.

RAQA.CH: Global mock FDA inspection services led by former FDA investigators. Providing quality assurance and regulatory affairs consulting at reasonable costs.

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