Dedicated Outsourced Audit Solutions

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Organizations dedicated to developing therapies for rare and orphan diseases and advanced therapies operate under unique pressures. The regulatory environment is complex, demanding rigorous quality control and compliance, yet resources are often constrained. Managing the necessary audits—internal QMS assessments, critical supplier evaluations, and preparing for regulatory inspections—can place a significant burden on your valuable quality and regulatory teams. This necessary activity can divert crucial attention, time, and funding away from your core mission: advancing research, developing life-changing therapies, and supporting patients.

Imagine empowering your expert teams to fully dedicate their time to accelerating therapy development, navigating complex manufacturing challenges for novel modalities (like ATMPs), managing change effectively, and strengthening the verification and validation essential for patient safety, rather than being consumed by the demanding audit cycle.

Regal Intel offers a specialized solution: comprehensive audit outsourcing services tailored specifically to the needs of the rare disease community. By partnering with us, you can strategically entrust your audit functions to experienced professionals who understand your context, ensuring robust compliance while freeing up your internal resources to focus where they matter most.

Maintaining a comprehensive in-house audit program within the often resource-constrained rare disease environment involves significant direct and indirect costs that impact your ability to deliver on your mission.

Direct Costs:

• Personnel: Salaries, benefits, and overhead for quality/regulatory staff spending substantial time on audit activities, often stretching lean teams.
• Travel: Expenses for conducting audits of specialized suppliers or partners, which can be challenging for budget-conscious organizations.
• Training: Continuous investment needed to keep auditors current on evolving global regulations and specific requirements for rare disease therapies (e.g., ATMPs, orphan designations).
• Software & Tools: Costs associated with audit management software and IT infrastructure.
• External Expertise: Occasional fees for specialized consultants needed for niche areas.

Indirect Costs:

• Resource Diversion: Quality and regulatory experts pulled away from critical mission activities like R&D support, clinical trial oversight, manufacturing scale-up, regulatory strategy, or patient engagement initiatives.
• Potential Delays: Inefficiencies or backlogs in the audit schedule can impact program milestones critical for meeting urgent patient needs.
• Limited Niche Expertise: Internal teams may not have broad exposure to best practices across diverse rare disease modalities or the specific nuances auditors encounter frequently.
• Objectivity Challenges: Maintaining perceived and actual objectivity can sometimes be challenging within smaller, closely-knit organizations.
• Compliance Risk: Inadequate or delayed audits can increase the risk of compliance gaps, potentially impacting patient safety, regulatory standing, and organizational reputation – stakes that are incredibly high for novel rare disease therapies.

Regal Intel provides expert audit services with a deep understanding of the rare disease regulatory landscape and a commitment to supporting your mission. As a non-profit ourselves, we understand the ecosystem. Our experienced auditors possess specialized expertise across all audit types relevant to rare disease programs, including:

• Internal Audits: Comprehensive assessments of your QMS against relevant standards (ISO, GMP, GCP, GDP, Part 1271) and specific requirements for your product type.
• Supplier & Third-Party Audits: Rigorous evaluation of critical suppliers (materials, components) and partners (CMOs, CROs, testing labs) vital to your specialized supply chain.
• Audit Preparation: Expert support and mock audits to ensure your team is fully prepared for regulatory inspections by FDA, EMA, and other global agencies, focusing on rare disease program specifics.

Partnering with Regal Intel for your audit functions allows your organization to optimize resource allocation and enhance focus:

• Reduced Operational Burden: Alleviate pressure on internal staff and budgets related to audit planning, execution, travel, training, and tool management.
• Enhanced Focus on Core Mission: Free up your key personnel to concentrate fully on research, development, clinical progress, manufacturing challenges, patient access programs, and other strategic priorities central to your mission.
• Access to Specialized Rare Disease Expertise: Benefit from the diverse experience, best practices, and specific knowledge of our auditors who regularly work with rare disease modalities (drugs, biologics, ATMPs, devices) and related compliance challenges.
• Improved Objectivity & Compliance Assurance: Gain impartial, reliable audit assessments, fostering greater confidence with stakeholders and regulatory agencies, while proactively identifying potential compliance gaps.
• Cost-Effective, Mission-Aligned Solution: Access expert audit services designed with a sensitivity to the financial realities of the non-profit and rare disease ecosystem.

The significant resource optimization achieved through partnership with Regal Intel can be strategically reinvested to directly fuel your core objectives:

• Accelerate Therapy Development: Empower your scientific and clinical teams to focus on innovation and bringing treatments through the pipeline faster.
• Strengthen Change Management: Dedicate necessary resources to effectively implement and manage complex changes associated with novel processes or scaling up production.
• Enhance Verification & Validation: Bolster V&V activities crucial for ensuring the safety, efficacy, and quality of unique rare disease products.
• Support Patient Access Initiatives: Allow greater focus on activities that directly support patient communities and facilitate access to therapies.

Track the positive impact of partnering with Regal Intel through key indicators relevant to your mission:

• Reduction in internal personnel hours and operational costs dedicated to audit functions.
• Increase in resources allocated to core R&D, clinical, and patient-focused initiatives.
• Improved timelines for audit completion supporting program milestones.
• Enhanced state of inspection readiness for your rare disease programs.
• Strengthened compliance posture and reduction in audit findings.

In the demanding field of rare diseases and advanced therapy, optimizing every resource to advance your mission is paramount. Regal Intel offers a strategic, non-profit partnership to alleviate the burden of audits, ensuring robust compliance while allowing you to reinvest valuable resources in what matters most – developing and delivering life-changing therapies to patients.

Contact Regal Intel today to discuss how our tailored outsourced audit partnership can support your organization.