Quality Policy

At BioCina, we offer services in compliance with regulations and guidelines from the most stringent regulatory authorities.

We provide a phase appropriate quality approach that earns the trust of our clients through all phases of our client programs, comprising of clinical trials, validation studies and product approvals. Quality is core to every aspect of all of our services. This Quality Policy document outlines our quality mission, commitment, and culture.

Our Quality Mission

We ensure highest quality processes and facility operations, adhere to the most stringent global regulatory standards and ensure quality is core to every aspect of all of our services.

Our Quality Commitment

We are committed to ensuring all products are manufactured and released in compliance with cGMP and the most stringent global regulatory standards.

  • Provide guidance and direction regarding quality standards and expectations to support high quality services and products for our clients
  • Always operate in accordance with the conditions of our regulatory licenses
  • Ensure products are manufactured and released in compliance with cGMP and regulatory standards
  • Define phase appropriate quality requirements for client programs
  • Monitor the health of the Quality System through internal audits and regular quality management reviews
  • Ensure all investigations are completed in a timely manner
  • Ensure equipment and facilities are qualified, validated, and maintained
  • Ensure all regulatory inspection and client audit responses are completed in a timely manner
  • Continuously educate and train all staff in the relevant SOPs
  • Implement initiatives to continuously improve the quality of our services

Our Quality Culture

  • Quality is our culture and is embodied by every member of our organisation
  • Senior management is committed to and accountable for ensuring a robust Quality System
  • Senior management consistently demonstrates strong and visible support for the Quality System
  • All team members comply with Good Documentation Practices, data integrity principles, and data governance policies
  • All members are empowered to ensure that cGMP standards are complied with

BioCina’s Quality Policy is implemented through its Quality Management System and is applicable to all BioCina team members, visitors, contractors, and other stakeholders.

Mark W. Womack

Chief Executive Officer

Melissa El Khouri

Head of Quality

Last Updated: July 15, 2024