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About Us
Welcome to Regal Intel
Welcome to Regal Intel, your dedicated partner committed to advancing BioTech therapies and rare and orphan diseases.
We provide specialized regulatory and quality guidance tailored to help innovators navigate the unique complexities of the BioTech and 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, quality system implementation, clinical affairs, site readiness, and ensuring sustained compliance within the rare disease ecosystem.
Our Specialization: Expert Support for BioTech and Rare Disease Therapies
Our specialization lies in guiding rare and orphan disease therapies through their unique development lifecycle. We have extensive experience managing the distinct challenges inherent in this field – from strategic planning for therapies targeting small populations and navigating adaptive clinical trial designs, to managing complex global product registrations. This includes securing orphan drug designations, leveraging specialized regulatory pathways (like FDA Fast Track/BTD, EMA PRIME), and efficiently achieving marketing authorization and licensing in key countries worldwide to accelerate patient access.
Our focus particularly includes strategies involving orphan drug designations, pediatric investigation plans (PIPs), and utilizing all available expedited pathways to secure timely marketing authorizations and product licensing globally, ensuring critical treatments reach patients faster.
Our deep, hands-on experience gained since 2001 across the broader BioTech industry provides a robust foundation for our dedicated work in the BioTech and rare and orphan disease space. This extensive background enables us to effectively address the diverse and complex challenges faced by organizations developing critical therapies.
Leveraging Our Experience for Your Rare Disease Mission
Our expertise is channeled to support your mission and includes:
- Establishing and Certifying Robust Quality Systems: Ensuring compliance with essential standards (GMP, ISO 13485, ICH) and multi-jurisdictional programs critical for the manufacturing integrity and global acceptance of often complex rare disease and BioTech therapies.
- Meeting Specific Market Access Requirements: Navigating specialized compliance and certification needs, including Halal, Kosher, and Animal-Origin Free processes, to ensure therapies can reach diverse patient populations globally.
- Managing Global Logistics Compliance: Expertly handling intricate import/export trade compliance crucial for international clinical trials and the distribution of specialized treatments across borders.
- Resolving Critical Regulatory Challenges: Successfully addressing and remediating significant compliance issues, including responding effectively to Regulatory Warning Letters and implementing corrective actions.
- Securing Global Regulatory Approvals: Proven track record in managing the full lifecycle of regulatory registrations and obtaining necessary licenses in numerous countries worldwide, adapted now for pathways relevant to rare diseases.