About Regal Intel: Expertise, Integrity, Mission Focus

The trusted non-profit 501(c)(3) partner leveraging AI-driven intelligence to accelerate therapies for rare and orphan diseases.

Regal Intel was built on the principle of providing unparalleled traditional product development, regulatory and quality expertise to the biotech sector. Leveraging this strong foundation, we've transitioned into a dedicated AI-powered organization focused exclusively on the critical needs within the rare and orphan disease space.

Our Non-Profit Mission:

To provide exceptional, dedicated support that empowers rare disease innovators to confidently navigate unique global regulatory and compliance challenges.

Our Ultimate Aim:

To accelerate the development and accessibility of safe, effective treatments for rare and orphan disease patient communities worldwide.

Our Vision

To be the most trusted partner for the rare disease community, recognized globally for our deep expertise in navigating rare disease pathways, our collaborative spirit, effective solutions, and unwavering commitment to advancing therapies and improving patient lives.

Our Core Values

⚙️ Expertise 🛡️ Integrity
🤝 Collaboration. 🎯 Mission Focus
⚡ Impact & Urgency ✅ Commitment

Commitment to the BioTech and Rare Disease Community: Our team works as an extension of your own, facilitating access across the US, EU, and other key global markets.

Specialized Product Development, Regulatory & Data Expertise

Regulatory Expertise: Guiding Therapies

We combine decades of hands-on experience in the biotech and rare disease industries to guide therapies through their unique development lifecycle, from strategic planning for small patient populations to securing timely global marketing authorizations.

Orphan Drug Pathways: Utilizing all available expedited pathways and designations.
Pediatric Investigation Plans (PIPs): Ensuring therapies are accessible to pediatric patients.
Adaptive Clinical Trial Designs: Navigating complex clinical trial strategies.

We have successful cases of expedited regulatory approval using our AI-powered data analysis tool to transform real-world data into targeted real-world evidence.

Connect With Us

AI-Driven Regulatory Intelligence

Our expertise is channeled to support the mission of our partners, with a core focus on eliminating regulatory hurdles and expediting regulatory approvals. Our guidance includes:

Real-World Data for Expedited Approval: We provide expertise in compiling data from various sources for product development, regulatory submissions, including electronic health records, patient registries, biobanks, and patient-generated data.
Global Market Access: We help our partners navigate specialized regulatory compliance and certification needs, such as Halal, Kosher, and Animal-Origin Free processes, to ensure therapies can reach diverse patient populations globally.
Regulatory Challenge Resolution: We offer support to address and remediate critical compliance issues, including responding to Regulatory Warning Letters and implementing corrective actions.
Securing Global Regulatory Approvals: We have a proven track record in managing the full lifecycle of regulatory registrations and obtaining necessary licenses in numerous countries worldwide.