About Regal Intel: Expertise, Integrity, Mission Focus

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Founded in 2001, Regal Intel was built on the principle of providing unparalleled regulatory and quality expertise to the BioTech sector. Leveraging this strong foundation, we have transitioned into a dedicated organization focused exclusively on the critical needs within the BioTech and rare and orphan disease space. We recognized the profound unmet needs and unique hurdles faced by innovators striving to bring life-changing therapies to underserved patient communities. Our commitment remains steadfast: to deliver practical, mission-oriented solutions with a sense of urgency driven by patient need, and with a sensitivity to cost-effectiveness essential for sustainable impact in this field.

To provide exceptional, dedicated regulatory and quality support that empowers rare disease innovators—companies, researchers, and patient-focused organizations—to confidently navigate unique global regulatory and compliance challenges. Our ultimate aim is to accelerate the development and accessibility of safe, effective treatments for rare and orphan disease patient communities worldwide.

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.

• Expertise: Deep, practical understanding of global clinical, regulatory and quality requirements, specifically applied to the nuances and challenges of rare and orphan diseases, providing insightful, actionable guidance. 
• Integrity: Operating with the highest ethical standards in all interactions, ensuring transparency, confidentiality, and unwavering trust in our partnerships. 
• Mission Focus: An unwavering dedication to the goals of our partners and the ultimate aim of serving the rare disease community; tailoring solutions to advance their specific mission and maximize patient impact.
• Collaboration: Believing that progress is accelerated together, we work closely with our partners as a seamless extension of their team, fostering strong relationships built on shared goals and mutual respect.
• Impact & Urgency: Driving tangible progress by delivering efficient, effective solutions that overcome hurdles and accelerate patient access, recognizing the critical importance of time for patients awaiting treatments.

Our team comprises seasoned professionals with decades of experience applying their knowledge to the BioTech and rare disease landscape. We pride ourselves on our proactive approach, meticulous attention to detail, and our commitment to building strong, collaborative partnerships. Functioning as an extension of your own team, we work alongside you to achieve your critical regulatory compliance milestones and mission objectives, facilitating access across the US, EU, and other key global markets for the patients who need it most.