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    • RWE/RWD
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    • Biologics
    • >> BLA
    • Combination Products
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    • Mergers & Acquisitions
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    • Regulatory Affairs

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Supporting AI-powered Drug & Biologic Development

Executive Summary

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.

Accelerating Development for Rare Disease Therapies

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.

AI-Powered Clinical & Regulatory Support

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:


  • Clinical Trial Design: Guidance on protocol development and strategies for robust data management with potentially sparse data. Our platform provides input on trial design to optimize for rare conditions and ensures compliance with ICH-GCP.
  • Regulatory Submissions: We specialize in preparing and managing comprehensive regulatory dossiers, including Biologics License Applications (BLAs), New Drug Applications (NDAs), and Marketing Authorisation Applications (MAAs). We expertly integrate requirements for Orphan Drug Designation (ODD), pediatric plans, and expedited pathway designations, ensuring meticulous eCTD submissions to global health authorities.
  • Specialized Technical Writing: Our team excels in creating clear, concise documentation for rare disease therapies, including complex CMC documentation and Clinical Study Reports (CSRs). We ensure adherence to cGMP and ICH guidelines.

CMC Strategy & Pharmacovigilance

We provide AI-powered CMC and pharmacovigilance guidance critical for developing and controlling complex rare disease therapies like biologics, cell therapies, and gene therapies.


  • CMC Strategy & Support: We help develop robust and phase-appropriate manufacturing processes, validate sensitive analytical methods, and ensure strategies align with global regulatory expectations for product quality and consistency.
  • Pharmacovigilance: Our support helps you develop and implement tailored, global pharmacovigilance systems compliant with reporting requirements, including signal detection strategies suitable for sparse datasets and the development of Risk Management Plans (RMPs).

Global Regulatory Partnership

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.


Connect With Us

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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