Our Core Services

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Welcome to Regal Intel, your dedicated partner committed to advancing therapies for BioTech and rare and orphan diseases. We provide specialized regulatory, clinical, and quality guidance tailored to help innovators navigate the unique complexities of the rare disease landscape, accelerating the path for vital treatments to reach patients in need. Our support focuses on critical areas like global regulatory strategy, including orphan drug pathways, clinical affairs, quality system implementation, site readiness, and ensuring sustained compliance within the rare disease ecosystem.

As your non-profit partner, we offer comprehensive support specifically designed to address the unique challenges of developing and delivering therapies for rare diseases. Our services include:

• Global Regulatory Strategy & Submissions for Rare Diseases: Expert guidance on navigating the specific regulatory landscape for rare diseases worldwide. This includes developing strategies for and securing Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), Humanitarian Use Device (HUD/HDE) designation, and leveraging expedited pathways (e.g., FDA Fast Track, BTD, RMAT; EMA PRIME). We manage the preparation and submission of critical regulatory filings (IND, IDE, BLA, NDA, PMA, 510(k), MAA, CE Marking under MDR/IVDR) to key global agencies like FDA, EMA, TGA, NMPA, MHLW, Health Canada, Anvisa, and others, ensuring alignment with ICH guidelines and local requirements to achieve timely global patient access.
• Comprehensive Clinical Affairs Support & Trial Execution for BioTech products and Rare Diseases: We provide end-to-end clinical development services tailored to the intricacies of rare disease research. This includes strategic clinical trial design that addresses challenges such as small patient populations, endpoint selection, and data variability, powered by our in-house expert biostatisticians who ensure robust statistical planning, analysis, and interpretation. Our capabilities extend to full clinical trial management and execution, adhering to Good Clinical Practice (GCP) standards. We can function as your dedicated Clinical Research Organization (CRO) or seamlessly coordinate with and oversee other CROs and investigator sites to ensure efficient trial conduct, data integrity, and timely milestone achievement. Our focus is on innovative and adaptive trial methodologies to optimize evidence generation for rare disease therapies.
• Quality System Implementation & Auditing: Establishing efficient, phase-appropriate Quality Management Systems (QMS) compliant with cGMP, ISO 13485, ISO 9001, and supporting MDSAP certification. We tailor QMS implementation, site accreditation/certification readiness, and perform crucial 3rd party independent audits (internal, supplier qualification, mock regulatory inspections) specifically addressing the complexities often found in rare disease therapy manufacturing (e.g., small batch sizes, novel technologies, complex supply chains).
• Compliance Remediation & Regulatory Response: Providing expert, cost-effective support to address and resolve critical compliance issues. This includes developing effective strategies for responding to regulatory agency concerns, such as FDA 483 observations and Warning Letters, and implementing robust Corrective and Preventive Action (CAPA) plans for sustained compliance.
• Global Clinical & Commercial Supply Chain Compliance: Ensuring regulatory compliance throughout the specialized international supply chains vital for rare disease clinical trials and commercial distribution. This includes managing complex import/export trade compliance requirements and ensuring adherence to Good Distribution Practices (GDP).
• Specialized Market Access & Compliance: Assisting organizations in meeting specific compliance requirements necessary to ensure the broadest possible patient access across diverse populations and markets, including certifications such as Halal, Kosher, and demonstrating Animal-Origin Free compliance where required.
• Dedicated Support for Devices, Diagnostics & SaMD: Providing targeted regulatory and quality support for medical devices, including Software as a Medical Device (SaMD), combination products, and companion diagnostics crucial for rare disease management and treatment. This includes navigating EU MDR/IVDR requirements, FDA submissions (510(k), De Novo, PMA, HDE), and ensuring compliance for ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility).

Our expertise is applied across various product types, always with a focus on applications targeting rare and orphan diseases:

• Small Molecule Pharmaceuticals (including repurposed drugs)
• Biologics, Cell Therapies, and Gene Therapies
• Medical Devices (including SaMD) for Rare Disease Management & Treatment
• In Vitro Diagnostics (IVDR) & Companion Diagnostics
• Combination Products tailored to Rare Disease Needs
• Advanced Therapeutics (e.g., Vaccines, Nucleic Acid-based therapies)