QMS Auditing: Supporting Quality Excellence

---

Ensuring robust quality management is fundamental to developing safe and effective therapies.

Robust QMS is required within the unique context of rare diseases where organizations may face specific challenges related to scale, novel technologies, and resources.

As a dedicated non-profit partner, Regal Intel provides expert, objective, and cost-effective QMS auditing services tailored to support the mission of rare disease innovators.

We conduct thorough, objective internal audits assessing the effectiveness of your Quality Management System (QMS) against applicable regulations and standards (e.g., ISO 13485, ISO 9001, FDA 21 CFR Parts 820, 210/211, 1271, relevant EU GMPs/ATMP guidelines) and your own internal procedures designed for rare disease products. Our audits identify areas for improvement and efficiency, ensuring your QMS effectively supports your quality goals and mission objectives. We provide detailed, actionable reports and recommendations to enhance processes and maintain a state of compliance readiness.

The integrity of the supply chain is critical, particularly when dealing with specialized materials, novel components (like vectors), or single-source suppliers common in rare disease therapy development. We help you effectively evaluate and manage your suppliers through comprehensive, risk-based audit programs. Our audits assess supplier quality systems and compliance, minimizing risks and ensuring the consistency and quality of materials and services vital for your rare disease program. We develop tailored audit plans and provide clear, actionable feedback.

Prepare your team for regulatory inspections by agencies like the FDA, EMA, and others with confidence. Regal Intel conducts meticulous pre-assessment audits and realistic mock inspections designed to simulate actual regulatory scrutiny. We focus on areas critical for rare disease programs (e.g., orphan designation compliance, ATMP manufacturing controls, clinical data integrity for small populations), identifying potential gaps and helping your team build readiness and mitigate risks effectively.

Leveraging advanced technology, we offer efficient and flexible remote audits. This approach provides valuable QMS insights and assessments without the need for on-site visits, offering a particularly cost-effective solution for our non-profit partners and for auditing global suppliers, helping maintain compliance oversight while managing resources prudently.

• Expert Auditors: Our team comprises experienced auditors with in-depth knowledge of global regulatory requirements and specific experience relevant to rare disease products (drugs, biologics, devices, ATMPs) and processes.
• Objective Assessments: We provide unbiased, thorough evaluations of your QMS effectiveness and compliance status.
• Mission-Aligned & Tailored Solutions: Our auditing services are customized to address the specific needs, scale, technology, and mission objectives of your rare disease organization.
• Actionable Insights: We deliver clear, actionable recommendations focused on driving continuous improvement, enhancing efficiency, and ensuring sustainable compliance.
• Global Compliance Expertise: We help you navigate the complexities of international regulations applicable to rare disease therapies and technologies.
• Cost-Effective Partnership: As a non-profit, we provide high-value auditing support sensitive to the resource considerations often present in the rare disease ecosystem.
• Focus on Sustainability: We aim to help build and maintain robust, efficient quality systems that support your long-term mission success.