Quality Commitment
KCAS Bio’s Quality Commitment underscores our global commitment to GLP‑compliant, client‑focused bioanalytical testing, regulatory rigor, and continuous improvement. While our Quality Department functions independently from Laboratory Operations, both work in seamless alignment to uphold compliance, exceed quality benchmarks, and deliver data with integrity.
Our quality policy
At KCAS Bio, quality is foundational — not only to how we operate, but to how we serve our clients and contribute to advancing human health. As a global CRO, we provide bioanalytical, biomarker, and analytical laboratory testing services with an unwavering commitment to scientific integrity, regulatory compliance, and client satisfaction. This is accomplished by following a Quality Management System structured on a cross-functional process-based framework which assures that our clients’ R&D programs (and their future patients) are always the focus.
The Chief Executive Officer along with Site Leaders, have overall responsibility for and are fully committed to supporting the Quality Management System and promoting a culture of quality.
You can download our full quality policy below:
Quality assurance
Staying Aligned with Global Regulatory Expectations
To stay current with evolving regulatory requirements, KCAS Bio leverages multiple channels to access up-to-date guidance and industry insights, including:
- Electronic receipt of regulatory notices, (example such as those from FDA)
- Participation in industry groups such as Society of Quality Assurance (SQA) and French Quality Assurance Society (SOFAQ)
- Workshop on Recent Issues in Bioanalysis (WRIB), and AAPS PharmSci 360
- Attendance at industry conferences with related regulatory topics
- Webinar attendance of related regulatory requirements
Rigorous Regulatory Compliance Framework
- We adhere to FDA GLP (21 CFR Part 58) and FDA Electronic Records and Signatures (21 CFR Part 11) across applicable projects.
- Our operations also comply with OECD Principles of GLP (ENV/MC/CHEM(98)17), supporting Mutual Acceptance of Data in OECD-member countries.
- We follow the latest FDA and EMA guidance, including M10 Bioanalytical Method Validation, immunogenicity assay validation, and clinical trial electronic data requirements.
Regulatory compliance
KCAS Bio operates its facilities in compliance with the following, as applicable:
- Food and Drug Administration (FDA) Good Laboratory Practice (GLP) 21 CFR Part 58
- FDA Electronic Records; Electronic Signatures 21 CFR Part 11
- Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice ENV/MC/CHEM (98)17
- FDA Analytical methods for an in vivo bioavailability or bioequivalence study 21 CFR 320.29
Regulatory guidance and guidelines (FDA)
KCAS Bio also follows the below guidance and guidelines:
- FDA Guidance for Industry, M10 Bioanalytical Method Validation and Study Sample Analysis, November 2022
- FDA Guidance for Industry, Bioanalytical Method Validation, May 2018 (Biomarkers)
- FDA Guidance for Industry, Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019
Other Regulatory Guidelines may be followed on a protocol or contract-specific basis.
Regulatory guidance and guidelines (EMA)
KCAS Bio also follows the below guidance and guidelines:
- EMA ICH guideline M10 bioanalytical method validation and study sample analysis, July 2022
- EMA Guideline for Good Clinical Practice (GCP) E6(R2), December 2016
- EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials, March 2023
Other Regulatory Guidelines may be followed on a protocol or contract-specific basis.
Regulatory guidance and guidelines (GCLP)
KCAS Bio also follows the below guidance and guidelines:
- GCLP: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples Good Clinical Laboratory Practice (EMA/INS/GCP/532137/2010)
- GCLP: Good Clinical Laboratory Practices (WHO -2009)
- GCLP; Good Clinical Laboratory Practices (RQA – 2012)
Other Regulatory Guidelines may be followed on a protocol or contract-specific basis.
Licenses and certifications
- Kansas State Board of Pharmacy Analytical Laboratory Certificate
- Department of Health and Human Services – Various Permits to Import
- Infectious Biological Agents, Infectious Substances, and Vectors
- U.S. Fish & Wildlife Service Import/Export License
- DEA Controlled Substance Registration Certificate
- Lyon, France GLP Certificate
- Lyon, France ISO 9001:2015 Certificate
- Ministry of Research Import – Export Authorization
Regulatory inspection history
- KCAS Bio has had over 18 FDA inspections in our company history.
- KCAS Bio has not had any studies rejected by any regulatory authority.
- Lyon, France has been successfully inspected for GLP compliance.
Electronic quality management system
KCAS Bio utilizes an integrated and validated global electronic Quality Management System which includes: Document Management, Change Management, Training Management, Audit Management, Deviation (Investigation) Management, CAPA Management, Supplier Quality Management and Client Complaint Management.
Our team brings diverse expertise across CRO environments and regulated frameworks including GLP, GCP, and GMP, with a specialized focus in Quality Assurance. Cross-trained and consistently calibrated, the QA team ensures every regulated project receives timely, standardized review — enabling us to meet client timelines without compromising compliance or data integrity.
All employees are empowered as a vital part of the Quality Management System through continuous training and education
Emphasis is placed on client communication and understanding needs prior to delivery on project scope. Those projects which require regulatory compliance are ensured to meet it via the quality system
Processes and procedures required to execute regulatory requirements are continuously maintained in a state of compliance
Management supports the quality system and ensures a safe working environment
Strategic company planning includes quality
Technological and scientific solutions are developed to offer up-to-date methodology
Global collaboration for international and multi-site projects is unified
Growth of infrastructure, equipment, automation, information systems and technology is continually advancing to meet required client expectations and required regulatory requirements
Client feedback is incorporated as a part of the continuous improvement of the Quality Management System
Management is responsible to review the effectiveness of the quality system, including the Quality Policy, Quality Manual and associated policies and procedures
Goals and objectives include focus on quality objectives and are measured to assure an environment of quality awareness
Our People
Agile, responsive and easy to work with
We prepare and adapt our services based on a deep understanding of your drug development ambitions and wider business objectives.