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Advanced Therapies & Rare Diseases: AI-Powered Solutions

Executive Summary

Regal Intel is a dedicated non-profit partner committed to helping innovators navigate the highly complex development, manufacturing, and regulatory landscape for advanced therapies, particularly cell and gene therapies. Our specialized guidance leverages AI to address challenges from intricate global pathways and clinical trial design to post-market stewardship, ultimately accelerating patient access to these transformative therapies.

AI-Powered Regulatory Strategy

Successfully bringing advanced therapies for rare diseases to patients requires navigating multifaceted regulatory requirements. Our AI-driven platform provides solutions for:


  • Expedited Pathways: We use AI to help secure and manage designations critical for rare diseases, including Orphan Drug Designation (ODD), Regenerative Medicine Advanced Therapy (RMAT), PRIME, Fast Track, and Breakthrough Therapy Designation.
  • Regulatory Submissions: We guide manufacturers through the complexities of Biologics License Applications (BLAs) and Marketing Authorisation Applications (MAAs), ensuring meticulous eCTD submissions to global health authorities. AI tools can accelerate the preparation of regulatory submissions, reduce human error, and proactively address anticipated queries to shorten review cycles.
  • Global Regulatory Strategies: We use AI-powered analytics to develop cohesive strategies for achieving patient access across international markets, tailored to the specific needs of these therapies.

AI-Driven Development & Clinical Trial Design

Clinical development for advanced therapies demands specialized expertise, particularly given the nature of these therapies and target populations. Our AI-driven platform provides guidance for:


  • Preclinical & Clinical Trial Design: We leverage AI to develop protocols tailored for rare diseases, addressing challenges like small populations, immunogenicity, and long-term follow-up studies. AI can help to identify the most promising candidates for corrective gene editing, increasing therapeutic success rates.
  • Manufacturing & CMC: AI can create simulations and predictive models to optimize manufacturing processes and reduce the experimental burden for cell and gene therapies. This helps ensure products meet stringent GMP requirements and that manufacturing processes can be scaled for clinical and commercial use.
  • Patient Safety & Follow-Up: We use AI to implement robust safety monitoring plans to manage unique potential risks, such as long-term or delayed adverse events. Our AI-powered solutions can also improve patient retention and reduce the burden of long-term follow-up studies by automating data collection and analysis.

Our Therapeutic Focus Areas

Our expertise is applied across various product types, always with a focus on applications targeting rare and orphan diseases. Our AI-powered platform provides support for:


  • Biologics (e.g., monoclonal antibodies, recombinant proteins)
  • Advanced Therapies (e.g., cell and gene therapies)
  • Specialized Vaccines
  • In Vitro Diagnostics & Companion Diagnostics

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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