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 oversight and inspection history
KCAS Bio's regulatory track record reflects extensive experience meeting regulatory expectations and maintaining confidence in the quality and integrity of our work.
United States
- KCAS Bio has had over 25 FDA inspections in our company history.
- KCAS Bio has not had any studies rejected by a regulatory authority.
Standards we operate under
KCAS Bio's quality system is built on internationally recognized standards for laboratory conduct, clinical sample analysis, electronic data, and quality management. Requirements are applied according to the study, protocol, or contract.
Good Laboratory Practice (GLP)
- FDA Good Laboratory Practice, 21 CFR Part 58
- OECD Principles of Good Laboratory Practice, ENV/MC/CHEM (98)17 and subsequent OECD consensus documents
Good Clinical Laboratory Practice (GCLP)
- EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010)
- WHO Good Clinical Laboratory Practice (2009)
- RQA Good Clinical Laboratory Practice (2012)
Good Clinical Practice (GCP)
Electronic records and data integrity
- FDA Electronic Records; Electronic Signatures, 21 CFR Part 11
- EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials (March 2023)
Quality management systems
- ISO 9001 (Lyon, France; certified)
Additional requirements may be applied on a protocol or contract-specific basis.
Bioanalytical guidance we apply
KCAS Bio aligns its scientific practices with guidance from major health authorities, and incorporates relevant guidelines into our bioanalytical work as appropriate to each study, protocol, or contract.
|
Application Area |
Guidance |
Issued by |
|---|---|---|
|
Method validation and study sample analysis |
ICH M10 Bioanalytical Method Validation and Study Sample Analysis: FDA, November 2022 / EMA, July 2022 |
ICH, adopted by FDA and EMA |
|
Biomarkers |
Bioanalytical Method Validation for Biomarkers (January 2025), using a fit-for-purpose strategy for the related Context of Use (CoU) |
FDA and EMA |
|
Immunogenicity |
Immunogenicity Testing of Therapeutic Protein Products: Developing and Validating Assays for Anti-Drug Antibody Detection (January 2019) |
FDA |
|
Bioavailability / bioequivalence |
Analytical methods for an in vivo bioavailability or bioequivalence study, 21 CFR 320.29 |
FDA |
How we deliver quality
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
Our Quality Department functions independently from Laboratory Operations. Both work in alignment to uphold compliance, exceed quality benchmarks, and deliver data with integrity.
Leadership commitment
KCAS Bio’s Chief Executive Officer and Site Leaders provide leadership oversight of the Quality Management System and foster a culture of quality across all sites.
Validated eQMS
Integrated systems support documentation, training, audits, deviations, CAPA, and more.
Experienced QA team
Our QA team brings diverse expertise across CRO environments and regulated frameworks including GLP and GCP. Cross-trained and consistently calibrated, the team ensures every regulated project receives timely, standardized review, so we can meet client timelines without compromising compliance or data integrity.
Staying current with regulatory requirements
- Electronic receipt of regulatory notices (e.g., from FDA)
- Participation in industry groups such as the Society of Quality Assurance (SQA) and the French Quality Assurance Society (SOFAQ)
- Workshop on Recent Issues in Bioanalysis (WRIB), AAPS PharmSci 360 and EBF OS
- Attendance at industry conferences and webinars on regulatory topics
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 Certificate
- Ministry of Research Import – Export Authorization
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.