Combination Products

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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, ensuring streamlined development and compliance across global markets.

Integrated strategies addressing PMOA determination, regulatory pathways, CMC, quality system harmonization, clinical trial data integration, labeling, risk management, and post-market surveillance for products combining drugs, devices, and/or biologics.

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

• PMOA Determination and Classification: Guiding manufacturers through the classification process.
• Regulatory Pathway Selection (FDA, EMA, etc.): Identifying the most efficient pathway for market access.
• Pre-Submission Meetings and Interactions: Facilitating communication with regulatory agencies.
• Global Regulatory Strategies: Tailoring strategies for diverse international markets.

The manufacturing of combination products requires integrated quality control and compliance across drug, device, and/or biologic components. Regal Intel provides expert consulting on:

• Integrated CMC Strategies: Ensuring seamless integration of manufacturing processes.
• Quality System Integration: Harmonizing QMS requirements for all components.
• Stability Studies and Shelf-Life Determination: Addressing the unique stability challenges of combination products.
• Facility Design and Compliance: Ensuring manufacturing facilities meet regulatory requirements.

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

• Integrated Clinical Trial Design: Developing protocols that address the combined effects of components.
• Data Integration and Analysis: Ensuring seamless integration of data from different components.
• Pharmacovigilance and Safety Monitoring: Monitoring safety across all components.
• Patient Dosimetry and Safety (if applicable): Addressing unique safety concerns for radiation-emitting or other device components.

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.