HCT/Ps and Cellular Therapies

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The regulatory landscape for HCT/Ps is complex, requiring specialized expertise in tissue banking, processing, and distribution. Regal Intel assists with:

• FDA 21 CFR Part 1271 Compliance: Ensuring adherence to regulations for HCT/Ps.
• Establishment Registration and Listing: Guiding manufacturers through the registration and listing process.
• Donor Eligibility Determination: Assisting with donor screening and testing requirements.
• Tissue Processing and Storage: Ensuring compliance with aseptic processing and storage standards.
• Distribution and Tracking: Establishing robust tracking systems for HCT/Ps.

Maintaining a robust QMS is crucial for HCT/P manufacturers to ensure product safety and quality and therefore AATB compliance. Regal Intel offers:

• QMS Development and Implementation: Tailored to the unique requirements of HCT/Ps.
• Gap Analysis and Remediation: Identifying and addressing QMS deficiencies.
• Auditing and Inspection Preparation: Ensuring readiness for regulatory inspections.
• Validation and Verification: Validating critical processes and equipment.

Clinical trials involving HCT/Ps require specialized expertise in tissue handling, administration, and safety monitoring. Regal Intel assists with:

• We assist in the design and implementation of clinical trials for cell-based vaccines and immunotherapies, ensuring patient safety and data integrity.
• This includes expertise in immune monitoring and biomarker analysis.
• IND Applications: Guiding manufacturers through the IND process for HCT/Ps.
• Clinical Trial Design and Protocol Development: Incorporating unique aspects of cellular therapies.
• Adverse Event Reporting and Management: Monitoring and reporting adverse events specific to HCT/Ps.
• Data Management and Analysis: Handling complex data from cellular therapy trials.

The convergence of cellular therapies and vaccine technologies is revolutionizing the prevention and treatment of diseases.

Regal Intel provides specialized expertise in navigating the regulatory landscape for cell-based vaccines and immunotherapies, ensuring compliance and accelerating development. We understand the unique challenges associated with these innovative approaches and offer comprehensive consulting services to support your efforts. 

• We guide the development and regulatory approval of cell-based vaccine platforms, including dendritic cell vaccines, antigen-presenting cell vaccines, and other cellular delivery systems.
• Our expertise encompasses CMC strategy, clinical trial design, and regulatory submissions for these novel vaccine technologies.

• We assist in the development of cellular therapies designed to enhance vaccine efficacy, acting as potent adjuvants.
• This includes guidance on regulatory pathways for cell-based adjuvants and combination therapies.

• We provide regulatory consulting for personalized cellular immunotherapies used in cancer vaccines, addressing the complexities of individualized treatment approaches.
• We can assist with the regulatory strategies for neoantigen based cellular therapies.

• We provide regulatory assistance for the manufacturing of viral vectors used in cell-based vaccines.
• This includes assistance with GMP compliance.

• We prepare and manage regulatory submissions for cell-based vaccines and immunotherapies, including INDs, BLAs, and MAAs.
• We facilitate communication with regulatory agencies, ensuring clear and efficient interactions.

• We provide regulatory assistance for the manufacturing of viral vectors used in cell-based vaccines.
• This includes assistance with GMP compliance.

"Ensuring the long-term safety and efficacy of HCT/Ps is essential. Regal Intel provides:

• Post-Market Surveillance Plans: Developing and implementing comprehensive PMS plans.
• Adverse Event Monitoring and Reporting: Tracking and reporting adverse events.
• Risk Management and Mitigation: Identifying and mitigating potential risks associated with HCT/Ps.
• We develop and implement post-market surveillance plans to monitor the long-term safety and efficacy of cell-based vaccines and immunotherapies.
• This includes expertise in adverse event reporting and risk management.