M&A Support for Advanced Therapies: AI-Powered Due DIligence

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Mergers, acquisitions, and divestitures in the rare disease and advanced therapy space carry unique regulatory and quality considerations. Regal Intel provides specialized, mission-focused guidance on these transactions, leveraging AI to perform thorough due diligence and ensure seamless integration of regulatory and quality systems. We ensure transitions are smooth, compliant, and prioritize the continuity of patient care and access.

We conduct thorough, objective regulatory due diligence specifically focused on a target's rare disease and advanced therapy assets and supporting systems. Our AI-powered platform transforms this process by:

• Accelerating Document Review: AI can analyze vast document collections, including contracts, patents, and regulatory filings, in minutes, allowing human experts to focus on higher-level interpretation and strategic judgment. It identifies key clauses, potential risks, and data inconsistencies that might be missed in a manual review.
• Assessing Regulatory Compliance: We use AI to analyze a target's regulatory history, compliance status (GMP, GCP, GLP), and agency interactions related to its rare disease programs. Our platform can also review a target's Quality Management System (QMS) for suitability in supporting the specific needs of the rare disease product.
• Evaluating IP Assets: For AI companies or those with AI assets, we use specialized due diligence to assess the provenance, ownership, and use of the AI models and training data to avoid potential liabilities.

Mergers and acquisitions require careful planning to ensure systems and data are seamlessly integrated. Regal Intel assists in developing and executing comprehensive integration plans with the following support:

• Mission-Focused Integration: We help you align global regulatory strategies and plan the seamless integration of QMS, regulatory processes, and SOPs, prioritizing the continuity of rare disease programs and patient access.
• Risk Assessment: Our AI platform identifies, evaluates, and develops mitigation plans for risks associated with M&A activities involving rare disease assets. AI can detect financial irregularities, regulatory violations, and supply chain vulnerabilities that could pose a risk to the transaction.
• Global Regulatory Alignment: We facilitate the alignment of global regulatory strategies for the combined entity, ensuring a cohesive plan that leverages the strengths of the new organization to expand patient access.

Our non-profit model offers objective guidance that prioritizes the long-term benefit to the rare disease community and mission continuity over purely commercial outcomes. This unique perspective, combined with our AI expertise, provides a thorough and cost-effective approach to M&A support.