Mission-Driven to Advancing BioTech and Rare Diseases

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Welcome to Regal Intel, where our sole focus as an organization is to accelerate the development and accessibility of treatments for BioTech and rare and orphan diseases. We understand the uniquely challenging and constantly evolving regulatory and compliance landscape specific to this field. Founded on principles of deep, practical expertise gained since 2001, and now driven by a commitment to patient impact, we provide actionable quality and regulatory intelligence. Our strategic guidance is tailored specifically for innovators—companies, researchers, and consortia—working tirelessly within the rare disease ecosystem. Our mission is to empower these efforts, facilitating the path for safe and effective therapies to reach underserved patient communities efficiently and sustainably.

Our team comprises seasoned professionals with decades of hands-on experience in global regulatory affairs, quality assurance, and the specific demands of biologic, device, and pharmaceutical development. We now dedicate this wealth of knowledge exclusively to supporting the rare disease community. We have a proven track record helping organizations navigate highly complex regulatory pathways critical to this space, such as Orphan Drug Designation (ODD), Humanitarian Device Exemption (HDE), Pediatric Investigation Plans (PIPs), PRIME, Fast Track, and Breakthrough Therapy Designation, alongside standard procedures in the US, EU, and key global markets. We pride ourselves on a proactive, meticulous approach, driven by the urgency of patient need and dedicated to providing cost-effective, tailored solutions that meet the unique requirements of each rare disease program.

Regal Intel provides expert, non-profit guidance across the entire product lifecycle to navigate the complex journey of rare disease innovation. Our experience includes supporting the development and regulatory strategies for:

• Critical diagnostic tools (biomarkers, assays) and targeted therapies (including vaccines, gene therapies, specialized biologics, and target enrichment) specifically for rare conditions.
• Novel medical technologies, devices, or combination products uniquely suited to the needs of rare disease patients, including support for prototyping, testing, and assessing regulatory viability.
• Appropriate advanced materials research and selection ensuring biocompatibility and suitability for specialized rare disease applications.
• Development of robust Clinical Evaluation Reports (CERs) and Biological Evaluation Reports (BERs), adeptly addressing the challenges often associated with limited clinical data in rare populations through close collaboration with medical and scientific experts.

Our unwavering commitment is to facilitate the journey of effective and safe rare disease solutions from concept to the patients who urgently need them, ultimately improving outcomes and enhancing quality of life.