Quality Commitment and Compliance
KCAS Bio’s Quality Commitment underscores our global commitment to GLP / GCLP 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.
Quality at a glance
Quality at KCAS Bio is embedded in how we conduct science, manage risk, and protect the integrity of the data supporting critical development decisions.
Independent QA Oversight
Objective quality oversight separate from Laboratory Operations.
Global Compliance Framework
GLP, GCLP, FDA, EMA, OECD, and applicable international guidance.
Validated eQMS
Integrated systems supporting documentation, training, audits, deviations, CAPA, and more.
Regulatory Track Record
25+ FDA inspections and no studies rejected by regulatory authorities.
KCAS Bio’s Chief Executive Officer and Site Leaders provide leadership oversight of the Quality Management System and are committed to fostering a culture of quality across all sites.
You can download our full quality policy below:
Regulatory inspection history
- KCAS Bio has had over 25 FDA inspections in our company history.
- KCAS Bio has not had any studies rejected by a regulatory authority.
- Lyon, France has been successfully inspected for GLP compliance.
Regulatory alignment & compliance
KCAS Bio stays current with evolving regulatory requirements through multiple sources of guidance and industry insight, including:
- Electronic receipt of regulatory notices (i.e. 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 and webinars with related regulatory topic
KCAS Bio’s quality and compliance framework follows these applicable regulatory requirements and internationally recognized standards:
- 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
Connect with KCAS Bio to discuss how our quality approach supports your development goals.
Quality credentials
Licenses & 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 guidance and guidelines
KCAS Bio aligns its quality and scientific practices with applicable guidance from major health authorities and recognized laboratory organizations. We monitor evolving regulatory expectations and incorporate relevant guidelines into our bioanalytical practices, with additional requirements applied as appropriate to each study, protocol, or contract.
FDA
- FDA Guidance for Industry, M10 Bioanalytical Method Validation and Study Sample Analysis, November 2022
- FDA Guidance for Industry, Bioanalytical Method Validation for Biomarkers, January 2025 – Utilizing Fit-for-Purpose strategy for the related Context of Use (CoU)
- 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.
EMA
- EMA ICH guideline M10 bioanalytical method validation and study sample analysis, July 2022
- EMA Guideline for Good Clinical Practice (GCP) E6(R3), June 2026
- 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.
GCLP
- 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.
Our People
Our approach
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.
Responsibility beyond the lab
At KCAS Bio, integrity is built into everything we do.
From our EcoVadis sustainability assessment to our Responsible Procurement Policy, we hold ourselves to the same high standards in our business practices as we do in our science.
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.