Quality and Compliance

Established, Robust, and Flexible Quality Management System 
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A Phase-Appropriate, Quality-First Approach

BioCentriq has a comprehensive and established quality and compliance function with the personnel, systems, and procedures in place to apply phase-appropriate compliance and a quality-first approach to every program. Both Quality Assurance and Quality Control experts will be involved with your program from the very beginning as an integral part of the team starting with knowledge transfer and culminating with the release of your product. 

Members of the quality team will be engaged in everything from the initial qualification of the rooms and equipment to the validation and qualification of assays used during your manufacturing process and the successful release of your drug product or drug substance. 

Why BioCentriq?


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Current Knowledge of C&GT Specific Regulatory Guidance

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Experience With Phase-Appropriate Compliance

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Collaborative & Transparent Approach to Quality

An Overview of BioCentriq's Quality & Compliance


Since our founding, we have established the quality systems, team and procedures to support the development and manufacturing of novel cell and gene therapies.  This spans the testing of materials through to release and even regulatory support services. Please read more below.

Key Features of BioCentriq's Quality & Compliance Programs

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More Than 3,000 Square Feet of QC Laboratories  

Virtual Instructor Led Training

Testing Labs Adjacent to Manufacturing Suites 

BioCentriq Self-Paced Training Courses

World-Class Electronic QMS 

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Supporting Network of Qualified Vendors
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More Than 3,000 Square Feet of QC Laboratories  

Virtual Instructor Led Training

Testing Labs Adjacent to Manufacturing Suites 

BioCentriq Self-Paced Training Courses

World-Class Electronic QMS 

business meeting with people gathered around a table
Supporting Network of Qualified Vendors

    The Quality & Compliance Team

    There are close to twenty experienced scientists and analysts on the Quality and Compliance team at BioCentriq and they all have two things in common: an unwavering commitment to compliance and a passion for protecting the patient.

    Our team promotes a quality-first mindset across the company and is also sensitive to the fact that while standards must be designed with commercial manufacturing in mind, phase-appropriate considerations must and can be made to support the release of clinical materials.

    OUR PEOPLE
    “Coming from companies like BMS, Celgene, Legend and Rocket Pharma I understand the importance of continuously maintaining and improving product quality.”
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    Balazs Csoka, Ph.D.

    Senior Manager of Quality Control
    “I am a molecular bio-scientist who has had the privilege of working in a GMP environment and I am always looking for ways to apply continuous improvement to our production.”
    Zainab

    Zainab Alali, Ph.D.

    Associate Director of Quality Assurance

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    FAQs About Our Quality & Compliance Programs

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