Our Quality Commitment
Our Quality Commitment

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 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.

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A Robust Quality Approach to Upholding GxP Regulatory Compliance

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.

Our Quality Statement

biomedical quality system

“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.”

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glp gmp clia cro

An Advanced Quality Policy to Drive Scientific Excellence

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 BioAgilytix’s QMS. Encompassed within the manual are identifiable processes and systems that demonstrate adherence to applicable GxP (GLP, GCP, and GMP) regulatory requirements and standards.

BioAgilytix’s labs operate in accordance with 21 CFR Part 58 and our European lab is GLP certified. Our labs in Boston, MA and Durham, NC are also CLIA certified to perform lab-developed tests that are subject to CLIA oversight. Our Durham laboratory is additionally able to offer services under GMP.

BioAgilytix’s Quality team is responsible for providing an effective and efficient system and regulatory counsel for our operational units, addressing QA aspects related to our science, technologies, information, and services in a cohesive manner. Quality operates independently from these 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.

Led by Proven Quality Experts

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 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:

experienced qa team

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

computer system validation and equipment qualification

Computer System Validation and Equipment Qualification

cfr 21 part 11 expertise

Record Management and Archival

specialized large molecule focus

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

platform comparison guide

bioagilytix platform line-up infographic

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.

Read More

Integrating Quality into Every Aspect of our Bioanalytical Services

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.

quality processes

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.

quality clean environment

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.


quality and integrity

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.

quality across platforms

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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