Our Expertise: Where Technology Meets Regulatory Strategy

A holistic approach to accelerating the rare disease product lifecycle

Bridging Local Care with Global Cures

The gap between clinical care and clinical research is costing lives. 80% of rare disease patients are treated in community hospitals that are disconnected from the global research ecosystem.

Regal Intel bridges this gap. We are a non-profit consortium that deploys enterprise-grade technology to solve the logistics of rare disease research. We don't just advise; we build the infrastructure that allows data to flow securely between those who treat patients and those who cure them.

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For Hospitals & Health Systems

Your Data Stays. The Research Comes to You

Historically, participating in clinical research meant exporting sensitive patient files to a centralized database—a security risk many hospitals cannot take. We flipped the model.

Sovereign Intelligence: We deploy our AI containers locally, behind your firewall. The algorithm visits your data, learns from it, and returns only the anonymous insights. Zero patient records ever leave your facility.
Democratized Access: By joining the Regal Intel network, community hospitals can offer their patients access to global clinical trials and cutting-edge therapies that were previously reserved for major academic centers.
Revenue & Reputation: Turn your historical data archives into a valuable asset for research without compromising privacy or compliance (HIPAA/GDPR).

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For Biotech, Pharma & Life Sciences

De-Risking the Path to Approval

Developing therapies for small patient populations presents unique challenges: finding patients is hard, and proving efficacy without a large placebo group is even harder. We provide the evidence you need to convince regulators.

Synthetic Control Arms (SCA): We use our network to generate high-fidelity external control arms, reducing the need to recruit patients for placebo groups.
Regulatory-Grade RWE: We don't just scrape billing codes. Our AI reads unstructured clinical notes to extract the deep phenotypic data required for regulatory submissions (IND, NDA, BLA).
Global Market Access: We align your evidence generation strategy with the requirements of both the FDA and EMA, ensuring your data supports global approval.

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Our Specialized Expertise

We combine our "Sovereign AI" technology with decades of traditional regulatory consulting experience. Our team acts as an extension of yours, navigating the complex milestones of orphan drug development.

1. Regulatory Strategy & Intelligence

We specialize in the specific pathways designed to accelerate rare disease therapies.
Designations: Orphan Drug, Rare Pediatric Disease (PRV), Breakthrough Therapy, and RMAT designations.
Meetings: Preparation and strategy for FDA Pre-IND, End-of-Phase 2, and Pre-BLA meetings.
Global submissions: Managing IND, NDA, BLA (US) and MAA (Europe) lifecycles.

2. Chemistry, Manufacturing & Controls (CMC)

Manufacturing complex biologics for small populations requires precision.
Gene & Cell Therapy: Specialized support for HCT/Ps and advanced therapy medicinal products (ATMPs).
Supply Chain: Ensuring resilience for ultra-low volume, high-value supply chains.
Quality Systems: Building scalable QMS that is audit-ready for commercialization.

3. Real-World Evidence (RWE) Generation

Turning raw hospital data into regulatory assets.