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Quality Assurance and Regulatory Services


Robust quality and regulatory support protects our clients and ultimately patients.

Center for Breakthrough Medicine employee using advanced therapy quality assurance and regulatory equipment

Focus on compliance and continuous improvement

At the Center for Breakthrough Medicines, our advanced therapy quality management systems and regulatory services provide the highest level of compliance, control, and oversight for our client programs from the inception of the clinical trial through commercialization. Having a dedicated regulatory team on site supporting your program will allow for real-time process information and analytical data to be procured, evaluated, and applied to your submission filing. The requirements of an IND/BLA are complicated and can be difficult to interpret. By partnering with CBM, we can utilize our strong relationships with the health authorities and collaborate with you to make sure your filing meets the stringent requirements set forth by the agencies, minimizing any potential delays to your program resulting from the review process.
CBM has established a globally compliant and automated quality management system that provides phase-appropriate compliance to the clinical trial, while always ensuring the highest level of compliance needs as the program transitions to commercialization. We focus on continuous improvement and excel at meeting client timelines and deliverables. Our quality management systems were designed to comply with both US and EU regulations, and our single-site manufacturing facility was also designed, commissioned, and qualified to comply with regulations in both regions.

Regulatory strategy and advisory process

Our experienced regulatory team engages in collaborative communications with our clients and the regulatory authorities to support successful submissions and acceptance of all regulatory documentation and application information, providing a seamless, regulatory pathway for our clients’ advanced therapy programs. Our services include INTERACT, pre-IND and pre-BLA meetings, end-of-phase meetings, Breakthrough Therapy designation / PRIME meetings, Type A,B,C meetings, and scientific and data-based strategic planning and guidance.
Center for Breakthrough Medicine employee using equipment for cmc regulatory and impd regulatory services

Regulatory operations and application submission

Center for Breakthrough Medicines regulatory team provides strategic guidance throughout chemistry, manufacturing and controls (CMC) operations, establishment of specifications and operating ranges, method development and validation activities, process performance qualification (PPQ), and continued process verification, ensuring the creation, review, submission and maintenance of all necessary regulatory documentation, meeting the needs of the program and the authorities. This includes IND application and submission, BLA application and submission / marketing authorization approval, amendment and supplement submission packages, and briefing document packages.
We also ensure global regulatory requirements are built into our design build out of our facility operations for client programs. The FDA’s Pre-Operational Review process is utilized, where applicable, throughout the design and buildout phase. The development, deployment and surveillance of the quality program maintains compliance with current guidelines and adapts to changes in the industry and regulatory intelligence.

Discuss your regulatory needs or a quality-related questions

Change Management
Process & Production Control
Product Surveillance
Corrective & Preventive Action
Management Responsibility