Our Quality Commitment

Put your large molecule therapeutics in our expert hands, and we’ll give you confidence in the most accurate, precise, and comprehensive high-quality scientific processes, data and results.

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.

Quality Statement

“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 Quality Policy

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.

What is Advanced Quality and Why Does it Matter?

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.

Our QA Team’s Experience Includes:

  • Scientific, Nonclinical, Clinical, Diagnostic, Manufacturing and Regulatory US/EU Compliance Systems
  • Computer System Validation
  • Equipment Qualification
  • Record Management and Archival
  • Vendor Management
  • Quality Support of Multiple Therapeutic Areas
  • Leaders in Quality Organizations

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.

Our Quality Expertise:

  • Compliance to GLP, GCP, and GMP Relevant Regulations and Guidances
  • CFR 21 Part 11, Annex 11, Annex 15, and USP <1058>
  • Quality Assurance Team Averaging 20 Years of Experience
  • Advanced Quality Commitment in Every Aspect of Operations

BioAgilytix Quality Assurance

How Does BioAgilytix Redefine Quality Excellence in Bioanalytical Services?

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.

Assuring Compliance with a Quality Team.

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.

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.

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.

Quality: It’s in Our Mission

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.

Let us help you bring quality to the complexities of biologics.

Discuss your project with a quality professional