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Regal Intel offers dedicated AI-powered support to accelerate the development, approval, and accessibility of drugs and biologics. Our expertise spans unique clinical trial challenges, preparing specialized regulatory submissions, managing complex CMC for advanced therapies, and guiding programs through global regulatory agencies to achieve patient access.
Regal Intel is a non-profit partner committed to supporting organizations developing innovative pharmaceuticals and biologics for rare diseases. Our comprehensive support services leverage deep industry expertise gained since 2001, now focused entirely on navigating this unique landscape with AI. We partner with you from preclinical considerations and clinical strategy through global regulatory approval and post-market stewardship, aiming to bring vital therapies to patients faster and more efficiently.
Our AI-powered platform provides expert guidance tailored to the complexities of clinical trials and regulatory submissions for rare disease therapies. We offer support for:
We provide AI-powered CMC and pharmacovigilance guidance critical for developing and controlling complex rare disease therapies like biologics, cell therapies, and gene therapies.
Regal Intel offers comprehensive regulatory partnership across diverse global markets. We possess deep expertise in the specific requirements and pathways for rare disease therapies within key agencies including the FDA (US), EMA (Europe), NMPA (China), TGA (Australia), PMDA (Japan), and Anvisa (Brazil). We act as an extension of your team, providing tailored solutions to achieve and maintain global patient access.
Regal Intel, Inc. is a 501(c)(3) public charity. All contributions are tax-deductible to the extent allowed by law. Copyright © 2025 Regal Intel - All Rights Reserved.
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