Supporting AI-Powered Radiopharmaceutical Drug Development

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Regal Intel provides specialized, non-profit guidance to innovators developing complex radiopharmaceuticals for rare disease populations. We leverage AI to address unique challenges, including specialized regulatory submissions, complex CMC hurdles, clinical trial design, and pharmacovigilance, to accelerate access to these life-changing treatments.

Navigating the regulatory landscape for radiopharmaceuticals requires mastering both pharmaceutical regulations and distinct radiation safety requirements. Our AI platform provides comprehensive regulatory strategy development tailored for these therapies, integrating requirements for Orphan Drug Designation, expedited pathways, and pediatric plans. Our services include:

• Strategic Planning: Preparation for regulatory interactions, such as Pre-IND and Pre-NDA/MAA meetings.
• Dossier Compilation: Expert compilation and submission of dossiers, addressing both drug/biologic and radiopharmaceutical-specific data (e.g., dosimetry) in eCTD format.
• Dosimetry & Safety Assessments: Ensuring radiation dosimetry calculations and safety assessments meet stringent regulatory and ethical standards.

We provide expert guidance on clinical trials for rare disease radiopharmaceuticals, leveraging AI to enhance patient safety and data collection. Our support includes:

• Protocol Design: We design clinical trial protocols that incorporate radiation safety measures and patient-specific dosimetry calculations, addressing challenges of small and heterogeneous patient populations.
• Trial Optimization: Our AI platform helps with patient monitoring, emphasizing safety in potentially vulnerable populations. It also streamlines the trial process by using predictive analytics for patient categorization and recruitment.
• Data Analysis: We assist with statistically analyzing specialized imaging and dosimetry data, addressing challenges of small sample sizes.

We provide AI-powered solutions to tackle the unique challenges of manufacturing, safety, and distribution for radiopharmaceuticals.

• CMC & Manufacturing: We consult on establishing and maintaining GMP compliance for radiopharmaceutical production, developing robust analytical methods (addressing short half-lives), and optimizing facility design and radiation protection measures.
• Pharmacovigilance: Our AI models can uncover hidden patterns in pharmacovigilance datasets, allowing for earlier safety signal detection and more effective risk mitigation. We help implement tailored pharmacovigilance systems for efficient adverse event reporting and post-market surveillance.
• Logistics & Distribution: We provide guidance on optimizing "just-in-time" supply chains to reach geographically dispersed patients with time-sensitive products, leveraging AI to streamline operations.

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:

• Radiopharmaceuticals: Including diagnostic and therapeutic radiopharmaceuticals (theranostics).
• Therapies: Biologics, Cell Therapies, and Gene Therapies.
• Medical Devices: Including Software as a Medical Device (SaMD) and companion diagnostics.