Regal Intel: Leading Biotechnology Company

Your Partner in Advancing BioTech, Rare Disease Therapies

We feel humbled. Since 2001, Regal Intel has built a legacy of trust supporting pharmaceutical, biologic, and medical device innovators. We channel this deep expertise towards the critical mission of accelerating the development and accessibility of treatments for all diseases but especially rare and orphan diseases. We understand the unique hurdles faced by companies serving these patient communities – from navigating specialized regulatory pathways like orphan drug designations to managing complex global requirements with limited resources. Regal Intel is committed to empowering these innovators by providing comprehensive, mission-aligned regulatory, quality, and compliance solutions. Our goal is to streamline the journey from concept to patient, ensuring vital therapies reach those in need faster by meeting stringent requirements across key global agencies (FDA, EMA, NMPA, etc.).

Our Core Capabilities: Support for the BioTech Ecosystem

We offer a suite of services specifically tailored to help rare and orphan disease companies achieve and maintain global compliance and accelerate patient access:

Rare Disease Global Access Strategy & Execution: Expert guidance on navigating orphan drug designations, pediatric investigation plans, and efficient management of product registrations, site accreditations, and certifications (FDA, EMA, NMPA, etc.) for specialized therapies.
Robust Quality & Compliance Systems: Establishing and maintaining efficient, phase-appropriate Quality Management Systems (QMS) compliant with GMP, GDP, ISO 13485, ISO 9001, MDSAP, and more, tailored for the complexities often seen in rare disease manufacturing.
Clinical Trials: Accelerate your therapies with our specialized end-to-end clinical trial support. We partner with CROs/CMOs and offer expert strategic design, robust biostatistics, full trial execution, and seamless CRO/CMO coordination. Our patient-centric approach ensures efficient management focused on the unique needs of rare disease populations. We are dedicated to overcoming challenges to bring vital treatments to patients faster.
Expert Regulatory Submissions for Rare Diseases: Streamlining complex submissions, including FDA (Orphan Drug Designation, Fast Track, BTD, RMAT, IND, NDA, BLA, 510(k), PMA), EU (Orphan Designation, PRIME, Centralised Procedure, MDR/IVDR), and other global equivalents, leveraging specific rare disease incentives.
Specialized Clinical & Biological Evaluation: Ensuring product safety and performance with compliant Clinical Evaluation Reports (CERs) and Biological Evaluation Reports (BERs) addressing challenges like small patient populations and novel endpoints, meeting EU and ISO standards.
Comprehensive Post-Market Surveillance & Vigilance: Implementing robust, right-sized PMS solutions to maintain ongoing product safety and regulatory adherence for specialized patient populations.
Specialized Certifications for Broader Reach: Facilitating Halal, Kosher, and Animal-Origin Free certifications where needed.
Software & Technology Compliance: Providing expert guidance on regulatory submissions and validation, supporting digital health solutions including real world evidence (RWE) and real world data (RWD) and software applications often vital for rare disease management.
Effective Compliance Remediation & Response: Offering expert, cost-effective support to address regulatory challenges (e.g., FDA 483s, warning letters) and implement CAPAs efficiently.
Targeted Regulatory Strategic Intelligence: Leveraging our deep knowledge for actionable strategic guidance specific to the evolving rare disease landscape.
Supply Chain Integrity & Audits: Ensuring quality and compliance throughout the specialized supply chains often required for rare disease therapies via supplier qualifications and audits.
Process Optimization (Lean Six Sigma): Improving operational efficiency to maximize resource utilization for mission-focused organizations.
Regal Intel Verified Supplier Program: Streamlining supplier qualification for critical rare disease components and services, providing assurance within the ecosystem.
Regal Intel Certified Training: Equipping teams with practical regulatory affairs and quality compliance knowledge specific to the nuances of rare and orphan diseases.
Cost-Effective Outsourced Audit Function (internal, supplier): Allowing your team to focus on core R&D and patient access goals while we manage essential internal, pre-assessment, mock, and supplier audits with a non-profit sensitivity to cost.

The Regal Intel Advantage: Your Partner in Patient Impact

Choosing Regal Intel means partnering to advancing BioTech and rare and orphan disease therapies. We offer a unique advantage:

Deep, Focused Expertise: Our team comprises seasoned veterans with decades of hands-on experience, now applying this knowledge specifically to overcome rare disease regulatory challenges.
Mission-Driven Partnership: We function as an extension of your team, driven by the shared goal of bringing treatments to patients with unmet needs. Our solutions are tailored to your specific therapy and organizational context.
Proven Success in Complex Pathways: We have a demonstrable history of navigating the intricate regulatory hurdles common in rare disease development.
Commitment to Excellence & Cost-Effectiveness: We combine meticulous attention to detail with an understanding of the urgency tied to patient need, delivering high-quality, cost-effective solutions appropriate for the non-profit and rare disease environment.
Focus on Enabling Innovation: We manage the regulatory complexities, freeing your team to focus on the scientific innovation that brings life-changing products to the rare disease community.

Let us be your dedicated guide in navigating the global regulatory landscape to bring hope to patients.

Empowering BioTech, Rare Disease & Advanced Therapy Innovators

Empowering BioTech, Rare Disease & Advanced Therapy Innovators

Your Partner in Advancing BioTech, Rare Disease Therapies

Our Core Capabilities: Support for the BioTech Ecosystem

The Regal Intel Advantage: Your Partner in Patient Impact

Empowering BioTech, Rare Disease & Advanced Therapy Innovators

Empowering BioTech, Rare Disease & Advanced Therapy Innovators

Your Partner in Advancing BioTech, Rare Disease Therapies

Our Core Capabilities: Support for the BioTech Ecosystem

The Regal Intel Advantage: Your Partner in Patient Impact

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