International quality standards

We follow the guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), ISO 10993, US Food and Drug Administration (FDA) and other relevant health authorities.
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Good Laboratory Practice

The term “GLP,” or “Good Laboratory Practice,” refers to a quality system applicable to non-clinical studies that evaluate the safety and efficacy of chemicals, medical devices, and pharmaceuticals intended for use in humans, animals, or the environment. GLP encompasses a set of quality standards that ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety tests for chemicals and pharmaceuticals. The GLP quality system was adopted by the Organization for Economic Co-operation and Development (OECD) in 1992.

We obtained GLP certification in 2016 and have renewed it biannually since then. 

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ISO 13485 – Quality management systems for medical devices

This standard specifies the requirements for a quality management system that enables an organization to demonstrate its ability to manage products and services that meet customer requirements and applicable regulations. 

This management system can be applied by organizations involved in one or more stages of the life cycle of a medical device, including design and development; storage and distribution; installation; technical support; and final uninstallation and disposal, as well as the provision of related services (such as technical support).

We obtained ISO 13485 in 2024.
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Quality policy

Our commitment to quality is a fundamental element of Versa Biomedical business and daily operations, aimed at planning and executing preclinical studies in animal models. This Quality Policy is supported by a Quality Manual, which outlines the processes implemented in the (QMS). Management will take appropriate measures to prevent fraudulent or corrupt practices in any area of the company. Versa Biomedical strives for excellence in the following areas:

1. Services // 2. People // 3. Animal Welfare // 4. Quality Assurance Management

Consequently, our Quality Policy provides the framework that reflects our organization’s commitment to ensure quality, animal welfare, regulatory compliance, risk management, continuous improvement, and the satisfaction of both customers and employees, while maintaining a strong business focus.
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Openness on animal research

Versa Biomedical has joined the Openness on Animal Research agreement, promoted by the Federation of Scientific Societies in Spain (COSCE) in collaboration with the European Association of Research Animals (EARA), which was launched on September 20, 2016.
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ISO 9001

ISO 9001 is an international standard that outlines the criteria for a quality management system (QMS). It is part of the ISO 9000 family and emphasizes the importance of organizations meeting both sponsor and regulatory requirements. Versa Biomedical aims to achieve this accreditation in early 2025.

AAALAC certification

The AAALAC International accreditation program evaluates organizations that use animals in research, teaching, or testing. Through this voluntary accreditation program, it promotes the humane treatment of animals used in research. Versa Biomedical plans to obtain this accreditation in the near future.