Our Commitment to Quality

At BioAgilytix, our greatest commitment is to deliver unparalleled quality in bioanalysis. We aim to be the trusted partner for our clients, safeguarding integrity at every step. Through rigorous method validation and strict adherence to accreditation and certification standards, we ensure that our facilities, equipment, personnel, and practices meet the highest benchmarks for quality. 

Our commitment to quality—along with our unrivaled scientific expertise and technologies—allow us to provide our partners with the confidence of the most accurate, precise, and comprehensive high-quality bioanalytical testing services—with results that are delivered right on time, and right the first time.

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How commitment to quality ensures accurate and reliable results

A commitment to quality in bioanalytical testing services is of paramount importance to uphold scientific integrity, promote accurate data interpretation, and contribute to advancing the knowledge that improves patient care.

  • Accurate and reliable test results are crucial for making informed decisions. The quality of bioanalytical testing directly impacts the safety and efficacy of drugs, the diagnosis and treatment of diseases, and the assessment of environmental hazards. 
  • Maintaining high-quality standards instills trust and confidence among clients, collaborators, and stakeholders, fostering long-term relationships and enabling successful partnerships. 

To this end, regulatory bodies like the FDA, EMA, and ICH have developed globally recognized quality systems, such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). BioAgilytix strictly follows these guidelines.

BioAgilytix provides advanced quality control

While adherence to quality systems like GCP, GLP, and GMP are essential, it is not sufficient in supporting the advanced quality commitment that is required for the most complex bioanalytical projects and applications.

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 strictly adheres to our own advanced Quality Manual.

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 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.

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.

Benefits of partnering with BioAgilytix, a quality-focused service provider

When you partner with BioAgilytix for your program’s bioanalytical testing, you’ll benefit from our deep and sustained commitment to quality.

BioAgilytix ensures quality with our 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 in developing procedures and processes that support continual quality improvement.

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 rather an integral pillar of sustained excellence. 

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

Our commitment to quality translates into cost savings and risk mitigation for our partners by reducing the likelihood of errors, rework, and regulatory non-compliance. The accurate and reliable results we achieve for sponsors minimizes costly delays, improves decision-making, and prevents potential risks associated with compromised data integrity or regulatory penalties.

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Accreditation and certification for a quality policy that drives excellence in bioanalytical services 

BioAgilytix is committed to the highest levels of regulatory compliance and maintains a QMS that demands superior performance in everything we do. We understand the vital need for accreditation and certification as the foundation of a commitment to quality.

Our 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.

Learn more about the BioAgilytix commitment to quality: