HCT/Ps and Cellular Therapies: AI-Powered Intelligence

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Regal Intel provides expert regulatory guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), a complex class of products that require specialized expertise. We leverage AI to streamline compliance with regulations like FDA 21 CFR Part 1271, enhance donor eligibility determination, and manage the unique challenges of clinical trials and post-market surveillance for these therapies. Our mission is to accelerate the development and accessibility of safe, effective treatments for rare disease patient communities worldwide.

The regulatory landscape for HCT/Ps is complex, with a tiered, risk-based approach. We provide tailored support to navigate this environment, including:

• FDA 21 CFR Part 1271 Compliance: We assist with adherence to regulations for HCT/Ps, including establishment registration and listing, donor eligibility determination, and Current Good Tissue Practice (CGTP). Our AI-driven tools can help automate data collection for these processes and ensure records are maintained to prevent communicable disease transmission.
• GMP & QMS: We help you maintain a robust Quality Management System (QMS) compliant with Good Manufacturing Practices (GMP) and Current Good Tissue Practice (CGTP) standards, which is crucial for product safety and quality.
• Distribution and Tracking: We establish robust tracking systems for HCT/Ps, using AI to manage intricate logistics for potentially geographically dispersed patients or specialized treatment centers.

Clinical trials involving HCT/Ps require specialized expertise in tissue handling, administration, and safety monitoring. Our AI platform assists with:

• Clinical Trial Design: We leverage AI to design and implement clinical trials for cell-based vaccines and immunotherapies, ensuring patient safety and data integrity.
• Data Management: We handle complex data from cellular therapy trials, with AI tools that can process and analyze large datasets to identify patterns and insights that may be missed by traditional methods.

Ensuring the long-term safety and efficacy of HCT/Ps is essential, especially for those that have received expedited approval. Regal Intel provides AI-powered solutions for:

• Adverse Event Monitoring and Reporting: Our AI models can automatically analyze product complaints and other post-market data to identify and report adverse events, providing a more precise and proactive approach to patient safety.
• Risk Management: We help you develop and implement post-market surveillance plans to monitor long-term safety and efficacy, with AI tools that can perform literature searches more efficiently and effectively than manual methods.

The convergence of cellular therapies and vaccine technologies is revolutionizing disease prevention. We provide specialized expertise in navigating the regulatory landscape for these synergistic approaches, including:

• Personalized Cellular Immunotherapies: We offer regulatory consulting for personalized cellular immunotherapies used in cancer vaccines.
• Cell-Based Vaccine Platforms: We guide the development and regulatory approval of cell-based vaccine platforms, including dendritic cell vaccines and other cellular delivery systems.
• Viral Vector Manufacturing: We provide regulatory assistance for the manufacturing of viral vectors used in cell-based vaccines and ensure GMP compliance.