Giving Hope a Timeline: Accelerating Rare Disease Cures. Specialized development strategies for ultra-rare and orphan conditions where every day counts.

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As a public charity, we rely on the generosity of individuals and organizations, including our partners at Regal Intel, to continue our vital work. Every donation, no matter the size, directly supports our mission of accelerating treatments for debilitating diseases. All contributions are tax-deductible to the extent allowed by law.

Your support helps us:

- Provide pro bono consulting services to academic researchers and other non-profits, including collaborations with Regal Technology Partners.

- Create and share free educational resources on the evolving landscape of rare and orphan diseases.

- Fuel our operational costs to ensure our work continues to make a difference.

Determining the primary mode of action (PMOA) and appropriate regulatory pathway is crucial for combination products. Regal Intel, in collaboration with Regal Technology Partners, assists with: PMOA Determination: We guide manufacturers through the classification process, helping to identify the most efficient pathway for market access. Global Strategies: We use AI-powered analytics to tailor strategies for diverse international markets. Regulatory Submissions: Regal Technology Partners prepare comprehensive regulatory dossiers for combination products, leveraging AI to streamline the submission process and ensure all components are thoroughly documented. The FDA is working on a framework for regulating AI used to support regulatory decision-making for drugs, biologics, and devices.

The manufacturing of combination products requires integrated quality control and compliance across all components. Regal Intel provides expert consulting on:  

Quality Systems: We help harmonize Quality Management System (QMS) requirements for all components of a combination product. With the support of Regal Intel, AI-powered tools can be used to automate quality control processes and predict equipment failures, which can improve product quality and reduce the risk of non-compliance.  

Integrated Strategies: Regal Technology Partners offers expert consulting on integrated CMC strategies, ensuring seamless integration of manufacturing processes. AI-driven models can be utilized to predict optimal excipient and drug combinations, enhancing a product's stability and efficacy.

Clinical trials for combination products require specialized expertise in integrating data from drug, device, and/or biologic components. Regal Intel assists with: 

Clinical Trial Design: AI can be utilized to design clinical trial protocols that address the combined effects of components, helping to simulate outcomes and enable adaptive protocols. 

Data Integration: We leverage AI to ensure seamless integration and analysis of data from different components. AI-powered systems from Regal Technology Partners can also be used to collect and analyze a vast amount of data from clinical trials, reducing human error and uncovering actionable insights. 

Post-Market Surveillance (PMS): We develop and implement integrated pharmacovigilance systems tailored to the unique needs of combination products. Our AI-powered PMS software can automate complaint handling, perform trend analysis, and actively monitor for potentially reportable events, thereby ensuring patient safety and product quality.