Advanced Quality Driven by Advanced Science

Integrated Quality in Every Aspect of Our Science, Technologies, Information, and Services

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. Put your small and large molecule therapeutics in our expert hands, and we will give you the confidence of the most accurate, precise, and comprehensive high-quality scientific processes and data – with results that are delivered right on time, and right the first time.

Learn More About Our Quality Commitment:

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BioAgilytix provides integrated science, technologies, information, and services. We achieve this through a sustainable Quality Management System (QMS) built upon four key pillars:

Customer Understanding
BioAgilytix fosters deep insights into the working environment of our customers and identifies what they need to make their work simpler and safer.

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.

Regulatory Compliance
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.

Robust implementation and continuous education ensure the effectiveness of our quality system. Each day, we work to establish and monitor measurable quality objectives in order to deliver successful results for our sponsors.


“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 ensures quality with the employment of a highly experienced team devoted to compliance with appropriate regulations, policies, and operations. Averaging over 20 years of experience in bioanalytical quality assurance, our knowledgeable Quality team has extensive experience working in quality assurance and regulated environments. Their proven ability to uphold advanced quality is what helps BioAgilytix lead the industry standard for excellence in small and large molecule bioanalysis and related operations.

Our Quality team consists of leaders in Quality organizations, who have veteran experience supporting quality initiatives across a number of therapeutic areas. They are particularly experienced in upholding compliance to relevant GLP, GCP, GMP, and CLIA regulations and guidances, as well as in developing procedures and processes that support continual quality improvement.

Our QA Team’s Extensive Expertise Includes:

Scientific, Nonclinical, Clinical, Diagnostic, Manufacturing and Regulatory US/EU Compliance Systems

Computer System Validation and Equipment Qualification

Record Management and Archival

CFR 21 Part 11, Annex 11, Annex 15, and USP <1058> Expertise

Quality Made Possible by Angela Daniels, QC Specialist IV

Discover how Angela supports the premium science that we deliver each day in a Q&A session where she tells us about her expanding role at BioAgilytix.


In addition to scientific rigor 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.

By adopting an advanced quality mindset in every aspect of our daily work, we live out the dimensions of our quality commitment each day.

Implementing Processes that Drive Quality Results

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.

Clean lab workspaces at BioAgilytix

Maintaining a Clean, Safe Quality Environment

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.

Upholding Integrity in Everything We Do

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.

Applying Quality Across Bioanalytical Platforms

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.

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