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:

Download Quality Policy
Employees

All employees are empowered as a vital part of the Quality Management System through continuous training and education

Communication

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

Processes and procedures required to execute regulatory requirements are continuously maintained in a state of compliance

Management and working environment

Management supports the quality system and ensures a safe working environment

Company planning

Strategic company planning includes quality

Methodology

Technological and scientific solutions are developed to offer up-to-date methodology

Team collaboration

Global collaboration for international and multi-site projects is unified

Technology

Growth of infrastructure, equipment, automation, information systems and technology is continually advancing to meet required client expectations and required regulatory requirements

Feedback

Client feedback is incorporated as a part of the continuous improvement of the Quality Management System

Effective quality system

Management is responsible to review the effectiveness of the quality system, including the Quality Policy, Quality Manual and associated policies and procedures

Goal planning

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.

Our approach

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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:

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:

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 from ANSM
  • Lyon, France ISO 9001:2015 certification
  • 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 by ANSM 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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We prepare and adapt our services based on a deep understanding of your drug development ambitions and wider business objectives.

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