Expediting Development of Rare Disease Therapies for the Public Good
Contact Us: service@regalintel.com
Expediting Development of Rare Disease Therapies for the Public Good
Contact Us: service@regalintel.com
Accelerate Regulatory Approval with AI-Powered Intelligence
About Regal Intel
Unlock the future of regulatory submissions with AI
Regal Intel is building an AI-powered platform that accelerates drug development and regulatory approval for our partners, with a unique focus on real-world evidence (RWE) and diverse patient populations.
Our Mission
To accelerate the regulatory approval of life-saving therapies by providing expert, AI-driven intelligence to pharmaceutical and biotech partners, thereby helping them bring treatments to patients faster.
The Challenge: A Bottleneck in Therapy Development
The journey from a promising therapy to regulatory approval is long, complex, and costly. Key bottlenecks include:
- Clinical Trial Hurdles: Difficulty in recruiting enough subjects, especially from diverse and underserved communities, slows down trials and can impact approval.
- Regulatory Complexity: Navigating intricate and evolving global regulatory landscapes requires immense time and resources.
- Data Fragmentation: A lack of structured, high-quality real-world data (RWD) makes it difficult to generate the robust real-world evidence (RWE) needed to support regulatory submissions and reduce the need for extensive clinical trials.
These challenges delay the delivery of new treatments to patients who need them most.
Our Solution: AI-Powered Regulatory Intelligence
We're building an intelligent platform that transforms fragmented information into actionable regulatory insights. Our solution helps partners overcome the biggest hurdles in the submission process by focusing on three core pillars:
- Real-World Evidence (RWE) Generation: Our AI analyzes fragmented real-world data (RWD) to generate robust RWE, helping to justify the reduction of clinical trial subjects or even the number of trials required for regulatory review.
- Clinical Trial Optimization: We help partners identify and recruit subjects from diverse and underserved communities, accelerating trial timelines and ensuring comprehensive demographic representation for regulatory bodies.
- Regulatory Submission Readiness: Our platform provides partners with a holistic view of their data, helping them identify and prepare all necessary documentation for regulatory submission, including coordination with regulatory bodies for expedited approval processes.
Why Partner with Regal Intel?
Choosing Regal Intel isn't just about technology; it's about a strategic partnership built on trust and a shared mission. As a non-profit, we offer a unique competitive advantage:
- Unparalleled Data Access: Our trusted status as a non-profit encourages patients and patient advocacy groups to share the rich, longitudinal data crucial for RWE, which is often inaccessible to for-profit entities.
- Ethical Data Governance: We operate with a patient-first model, ensuring the highest standards of data privacy, security, and transparency. A patient advisory board oversees all data initiatives, reinforcing our commitment to the community.
- Commitment to the Cause: Any revenue generated from our commercial partnerships is reinvested into our non-profit foundation to support further data collection, research, and patient programs, creating a sustainable ecosystem for innovation.
Let us be your dedicated guide in navigating the global regulatory landscape to bring life-changing therapies to patients faster.