An Exceptional Commitment to Quality
Our commitment to quality runs through every aspect of our organization, from the development and deployment of robust quality systems that help ensure regulatory compliance and support audits, to continually striving for operational excellence and maintaining the integrity of our customers’ materials and data — all coordinated and supported by a team of expert and expertly connected project managers who are devoted to your success.
We believe that consistent quality is critical to success. One way we deliver on our commitment to quality is through our ability to demonstrate consistent, verifiable integrity of processes, data, and materials. We maintain a global, comprehensive and integrated Quality System based on regulatory requirements and industry best practices.
Our quality policies and standard operating procedures (SOPs) are implemented across our facilities, ensuring uniformity and adherence to customer and regulatory requirements. Our Quality System follows current Good Manufacturing Practices (cGMP) guidelines and complies with relevant governing bodies.
• US cGMP - Food and Drug Administration (FDA)
• 21 CFR 210, 211, 1271
• 21 CFR part 11 and part 58 (where applicable)
• US Drug Enforcement Agency (DEA)
• State pharmacy regulations
• Transportation Security Administration (TSA) Certification at 3 sites
• International Air Transport Association (IATA)
• Department of Transportation (DOT)
• Centers for Disease Control and Prevention (CDC) for A, B, and C priority pathogens
• ISO 9001:2015 certification (UK site)
• Parenteral Drug Association (PDA) guidelines for cold chain shipping
• In-house Qualified Person (QP) release at our United Kingdom facility
Our facilities around the world are regularly audited by regulatory authorities such as the US Food and Drug Administration (FDA), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medical Authority (EMA), and the Swissmedic for CH. Additionally, we host 70+ customer audits annually and maintain a comprehensive internal audit system to ensure compliance in all our operations.
For additional information regarding our current regulatory history and current registrations for both our US and UK facilities, please contact us.
Operational Excellence to Support Research
Research begins with gathering data and managing biospecimens. The ability to maintain the full integrity of both is the foundation of biobanking. Our teams of experts understand these fundamentals and incorporate operational excellence into their daily tasks, supporting research from the first lab test through the delivery of therapies to patients.
Our facilities and data systems are backed up and redundant on multiple levels. We have trained staff on-call at all times and every facility has a plan in case of a disaster. Our teams of biobanking experts have the knowledge and experience to advise on collection methods, provide the collection kits and supplies, and advise on optimal storage methods for downstream research.
Maintaining the integrity of our clients’ data is critical, as research is only as good as the data which supports it. Our proprietary IN-TRAK Biobanking Data Management System manages the data associated with valuable biospecimens. This validated, 21 Code of Federal Regulation (CFR) Part 11 compliant system helps protect data integrity throughout its lifetime:
• Sample registration
• Sample receipt
• Sample location management
• Request submission and approval
• Request fulfillment/sample preparation
• Shipment management
• Sample tracking and notifications
• Regulatory compliance/audit trail reporting
For enhanced decision-making and inventory monitoring, our customers have access to their samples, data, and clinical trial materials via a web-portal, 24/7/365, from any time zone in the world.