Quality Commitment
Although the Quality Department is independent of Laboratory Operations, both areas work within a culture of quality to achieve regulatory compliance, meet quality requirements and satisfy client expectations. Quality is built into our DNA and is every employee’s responsibility.
Our quality policy
KCAS Bio is a solution-based Global Company providing bioanalytical, biomarker and analytical laboratory testing services, which is committed to quality in all aspects from initial client contact to final data delivery.
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:
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
The team has varied experience including CRO, GLP, GCP and GMP backgrounds with exceptional focus in Quality Assurance. The team is cross-trained and calibrated to ensure that all regulated projects receive the same timely QA review to be able to meet client-required timelines.
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Quality assurance
In order to be well-informed of respective current and up-and-coming regulatory requirements, KCAS Bio has various ways to acquire up-to-date regulatory information. These include, but are not limited to:
- 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
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.
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