Combination Products with AI

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Combination products, which integrate drugs, devices, and/or biologics, present unique regulatory challenges. Regal Intel offers comprehensive consulting services to help manufacturers navigate these complexities, leveraging AI to streamline development and ensure compliance across global markets. Our expertise includes integrated strategies for PMOA determination, regulatory submissions, quality system harmonization, and post-market surveillance.

Determining the primary mode of action (PMOA) and appropriate regulatory pathway is crucial for combination products. Regal Intel assists with:

• PMOA Determination: We guide manufacturers through the classification process, helping to identify the most efficient pathway for market access.
• Global Strategies: We use AI-powered analytics to tailor strategies for diverse international markets.
• Regulatory Submissions: We prepare comprehensive regulatory dossiers for combination products, leveraging AI to streamline the submission process and ensure all components are thoroughly documented. The FDA is working on a framework for regulating AI used to support regulatory decision-making for drugs, biologics, and devices.

The manufacturing of combination products requires integrated quality control and compliance across all components. Regal Intel provides expert consulting on:

• Quality Systems: We help harmonize Quality Management System (QMS) requirements for all components of a combination product. AI-powered tools can be used to automate quality control processes and predict equipment failures, which can improve product quality and reduce the risk of non-compliance.
• Integrated Strategies: We provide expert consulting on integrated CMC strategies, ensuring seamless integration of manufacturing processes. AI-driven models can be used to predict optimal excipient and drug combinations, improving a product's stability and efficacy.

Clinical trials for combination products require specialized expertise in integrating data from drug, device, and/or biologic components. Regal Intel assists with:

• Clinical Trial Design: AI can be used to design clinical trial protocols that address the combined effects of components, helping to simulate outcomes and enable adaptive protocols.
• Data Integration: We use AI to ensure seamless integration and analysis of data from different components. AI-powered systems can also be used to collect and analyze a vast amount of data from clinical trials, which can reduce human error and uncover actionable insights.
• Post-Market Surveillance (PMS): We develop and implement integrated pharmacovigilance systems tailored to the unique needs of combination products. AI-powered PMS software can automate complaint handling, perform trend analysis, and actively monitor for potentially reportable events, which can ensure patient safety and product quality.

Preparing comprehensive regulatory submissions for combination products requires meticulous attention to detail and integrated documentation. Regal Intel assists with:

• Integrated Regulatory Dossier Preparation (NDA, PMA, BLA, etc.): Ensuring all components are thoroughly documented.
• eCTD Submissions: Streamlining the submission process with electronic common technical documents.
• Labeling and Packaging Compliance: Meeting specific regulatory guidelines for combination products.
• Risk Management and Mitigation: Developing and implementing strategies to mitigate risks associated with combination products.

Maintaining ongoing safety and efficacy monitoring is crucial for combination products. Regal Intel provides:

• Integrated Pharmacovigilance Systems: Tailored to the unique needs of combination products.
• Adverse Event Reporting and Signal Detection: Monitoring and reporting of adverse events across all components.
• Risk Management Plans: Developing and implementing strategies to mitigate risks.
• Post-Market Clinical Follow-up Studies: Ensuring long-term safety and efficacy.

Regal Intel possesses the expertise to help navigate the regulatory landscape for constituent parts of combination products. This includes expertise in:

• Device constituent parts: Assisting with the regulatory requirements for the device components of combination products, including device classification, risk assessment, and compliance with relevant standards (ISO 13485, etc.).
• Drug constituent parts: Navigating the regulatory requirements for the drug components of combination products, including CMC, preclinical, and clinical data requirements, and compliance with cGMP.
• Biologic constituent parts: Assisting with regulatory requirements for biologic components of combination products, including BLA submissions, cell and tissue requirements, and other related regulatory matters.