BioAgilytix is singularly committed to providing you with the scientific and regulatory expertise needed to overcome bioanalytical complexities and avoid quality pitfalls in every phase of development.
You’ll never have to worry about compromised quality with BioAgilytix as your partner. In fact, our commitment to advanced quality sets a new standard for excellence in bioanalytical operations.
“BioAgilytix Labs (BAL) is a contract laboratory registered with the FDA (FEI#3007929739) and has an established reputation of complying with the relevant national and international regulations and guidelines of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). BAL has a robust Quality Management System (QMS) detailed in a Quality Manual that details the BAL quality policy and a set of quality procedures that outline the necessary documented controls and compliance measures to ensure continual quality monitoring and improvement.”
BioAgilytix provides integrated science, technologies, information, and services. We achieve this through a sustainable Quality Management System (QMS) built upon four key pillars:
Performance and Reliability
BioAgilytix employs principles of design excellence to provide services that consistently address the needs of customers and other stakeholders. We develop and deliver services of superior quality and reliability that create high levels of customer loyalty.
BioAgilytix is committed to the highest levels of regulatory compliance and maintains a QMS that demands superior performance in everything we do.
Ownership and Accountability
BioAgilytix takes ownership and accountability for a QMS.
While standards like Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) are essential, they are not necessarily sufficient in defining the kind of advanced quality commitment that is demanded in the most complex bioanalytical projects and applications.
Advanced quality in bioanalytical services means more than strictly adhering to standards. In order for a quality commitment to be truly advanced, quality must permeate every aspect of operations, spanning data integrity, as well as safety, responsibility, and innovation. To that end, BioAgilytix maintains a quality manual that is strictly adhered to.
The Quality Manual documents are the organizational responsibilities, operations / systems, activities, quality policy, and procedures established for effective operation of the Quality Management System (QMS) for BioAgilytix. Encompassed within the manual are identifiable processes and systems that demonstrate adherence to applicable GxP (GLP, GCP, and GMP) regulatory requirements and standards.
Quality is responsible for providing an effective and efficient system and regulatory counsel for the operational units. Quality operates independently from the operational units and regularly performs quality review activities (e.g. in phase inspections, process / facility inspections, and vendor audits) to ensure compliance with appropriate regulatory regulations.
Along with capabilities, scientific rigor, efficiency, and technological advancement, quality is among the most critical indicators of bioanalytical CRO capability and performance. In order to ensure the integrity of results and the ability to meet pressing turnaround times, quality must not simply be a check in a box – but instead an integral pillar of sustained excellence.
We set a new standard for quality in bioanalytical services by adopting an advanced quality mindset in every aspect of our daily work. Learn about the dimensions of our advanced quality commitment below.
BioAgilytix ensures quality with the employment of a highly experienced team devoted to compliance with appropriate regulations, such as those for GLP, GCP, and GMP, as well as policies and operations. Our knowledgeable Quality team has extensive experience working in quality assurance and regulated environments.
Process is foundational to quality excellence. Our cohesive and collaborative quality team consistently upholds the highest quality and delivers on our commitment to provide superior science.
Our facility reflects our advanced commitment to quality. We maintain procedures to monitor and clean the laboratory environment as an integral aspect of upholding the ultimate levels of safety and reliability. A bioanalytical facility is an outward indicator of the quality of bioanalytical testing services that go on behind closed doors.
Integrity is an essential element of our advanced quality commitment. In a bioanalytical facility, integrity is upholding reliability, communication and transparency at every point in the client engagement. When it comes to quality, integrity means strict adherence to GxPs .
As an advanced quality facility, we are continually looking for quality improvements. We offer an array of advanced bioanalytical platforms, applying the same level of quality across each of these technologies – whether long-leveraged or newly emerging.
Quality is an integral aspect of what we do here at BioAgilytix. In fact, so integral is our advanced quality commitment that it is in our facility’s mission to provide quality, dependable bioanalytical support and expertise to the pharmaceutical and biotech community to more effectively bring their products to market.