About Quality Confidential

Quality Confidential, LLC ("Quality Confidential," "we," "us," or "our") is a regulatory and quality consulting firm headquartered in Pollocksville, North Carolina. We provide quality assurance, quality control, and regulatory affairs consulting services to pharmaceutical, biopharmaceutical, and medical device companies through a global network of senior-level consultants.

Our principal place of business is located in Pollocksville, NC. Questions regarding these Terms may be directed to info@qualityconfidential.com.

Acceptance of Terms

By accessing this website, submitting an inquiry, or entering into a consulting engagement with Quality Confidential, you agree to be bound by these Terms and Conditions and any applicable agreements, statements of work, or engagement letters executed between the parties. If you do not agree to these Terms, please do not use this website or engage our services.

Scope of Services

Quality Confidential provides professional consulting services in the following areas:

• Inspection readiness and regulatory remediation
• Quality Management System (QMS) design, implementation, and improvement
• Regulatory strategy, documentation, and lifecycle support
• Staff augmentation and embedded quality and regulatory expertise
• Technical documentation authoring and targeted training

The specific scope, timeline, deliverables, and fees for each engagement are defined in a written statement of work or engagement letter signed by both parties. These Terms apply in conjunction with, and do not supersede, any such executed agreement.

Confidentiality

Confidentiality is central to how Quality Confidential operates. We treat all information shared by clients — including inspection outcomes, FDA correspondence, CAPA plans, audit findings, and internal quality challenges — as strictly confidential.

Specifically, Quality Confidential will not:

• Display client names, logos, or affiliations on our website or in marketing materials
• Reference client engagements in public case studies or presentations without explicit written consent
• Disclose confidential client information to any third party except as required by law

Clients are similarly expected to maintain the confidentiality of Quality Confidential's proprietary methodologies, consultant network, pricing structures, and internal business information. Specific confidentiality obligations for each engagement are detailed in the applicable engagement agreement or mutual non-disclosure agreement.

Client Responsibilities

To enable Quality Confidential to perform services effectively, clients agree to:

• Provide timely access to relevant documentation, systems, facilities, and personnel
• Designate a primary point of contact for the engagement
• Review and provide feedback on deliverables within agreed timeframes
• Maintain accurate and complete records relevant to the engagement
• Inform Quality Confidential promptly of any material changes in regulatory status, inspection activity, or project scope

Delays or project impacts resulting from a client's failure to fulfill these responsibilities may affect delivery timelines and fee obligations.

Fees, Invoicing, and Payment Terms

Consulting fees are established in each engagement agreement or statement of work. Unless otherwise agreed in writing:

• Invoices are issued on a schedule specified in the engagement agreement (typically monthly or upon milestone completion)
• Payment is due within thirty (30) days of invoice date
• Overdue balances may be subject to a late fee of 1.5% per month
• Quality Confidential reserves the right to suspend services on accounts with balances outstanding beyond sixty (60) days

All fees are quoted and payable in U.S. dollars. Out-of-pocket expenses including travel, lodging, and materials are billed at cost and require prior written authorization.

Intellectual Property

Deliverables created specifically for a client engagement — including SOPs, protocols, reports, and training materials — become the property of the client upon full payment of applicable fees.

Quality Confidential retains ownership of:

• Proprietary methodologies, frameworks, templates, and tools developed prior to or independent of a client engagement
• General know-how and accumulated regulatory expertise of our consultant network
• All website content, marketing materials, and brand assets

Clients may not reproduce, distribute, or commercialize Quality Confidential's proprietary tools or methods without prior written consent.

No Guarantee of Regulatory Outcomes

Quality Confidential provides professional consulting advice and support based on the information available and the expertise of our consultants. However, we cannot and do not guarantee specific regulatory outcomes, including but not limited to:

• FDA or other agency approval of submissions, applications, or responses
• Absence of findings in regulatory inspections
• Acceptance of CAPA plans or remediation strategies by regulatory agencies

Our services are designed to strengthen compliance posture and improve inspection readiness. Final regulatory decisions rest with the applicable agency and are beyond our control.

Limitation of Liability

To the maximum extent permitted by applicable law, Quality Confidential's total liability to any client for any claim arising out of or related to services rendered shall not exceed the total fees paid by that client during the three (3) months immediately preceding the event giving rise to the claim.

Quality Confidential shall not be liable for any indirect, incidental, consequential, special, or punitive damages, including lost profits or regulatory penalties, even if advised of the possibility of such damages.

Nothing in these Terms limits liability for fraud, gross negligence, or willful misconduct.

Indemnification

Each party agrees to indemnify, defend, and hold harmless the other party and its officers, employees, consultants, and agents from and against any claims, damages, losses, or expenses (including reasonable attorneys' fees) arising from:

• A breach of these Terms or any executed engagement agreement
• Negligence or willful misconduct of the indemnifying party
• Infringement of any third-party intellectual property rights by the indemnifying party

Independent Contractor Relationship

Quality Confidential and its consultants provide services as independent contractors. Nothing in these Terms or any engagement agreement creates an employment relationship, partnership, joint venture, or agency relationship between Quality Confidential and the client or any individual consultant.

No Legal or Regulatory Practice

Quality Confidential provides consulting advice, not legal advice. Our consultants are quality and regulatory professionals, not licensed attorneys. Nothing in our services or communications constitutes legal counsel or establishes an attorney-client relationship. Clients are encouraged to seek qualified legal counsel for matters requiring legal expertise.

Website Use and Content

This website is provided for informational purposes. All content, including articles, service descriptions, and thought leadership materials, is the property of Quality Confidential and may not be reproduced without written permission.

We make reasonable efforts to keep website content accurate and current, but we make no warranties regarding the completeness, accuracy, or fitness of any website content for a particular purpose. Website content does not constitute professional consulting advice.

Governing Law and Dispute Resolution

These Terms and any engagement agreements are governed by the laws of the State of North Carolina, without regard to conflict-of-law principles. Any dispute arising under or related to these Terms shall first be subject to good-faith negotiation between the parties. If unresolved, disputes shall be submitted to binding arbitration administered in Wake County, North Carolina, under applicable arbitration rules.

Modifications to These Terms

Quality Confidential reserves the right to update these Terms at any time. Changes will be posted on this page with a revised effective date. Your continued use of our website or services following a posted update constitutes acceptance of the revised Terms. Material changes affecting active engagements will be communicated directly to affected clients.