
Quality Assurance
Our Quality Policy stands to achieve the highest attainable level of quality in the provided analytical services to the pharmaceutical, biopharmaceutical, cell & gene therapy industry. These services include laboratory activities, reporting, project management and scientific/regulatory advice throughout the drug development process. The analytical services range from preclinical studies to release of product batches for patient supply. Through continuous process optimization, standardisation and quality trainings of all employees we aim at exceeding customer expectations. In agreement with our customers and depending on the phase of drug development, our quality mindset is sufficiently flexible to find the right balance between good analytical practices and risk-based decision making.
The independent Quality Assurance team is responsible to oversee and promote quality achievement, to ensure compliance of the quality systems with applicable (inter)national standards and legislation, to define quality policies and procedures, to set up and maintain control of documentation and to contribute to both internal and external audits.
GMP compliance
Anabiotec is committed to Good Manufacturing Practices in accordance with EudraLex – Volume 4 Good Manufacturing Practice (GMP), Directive 2003/94/EC and directive 91/412/EEC and FDA 21CFR part 210-211, 21CFR part 820).
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Human Medicinal Products Veterinary Medicinal Products Human Investigational Medicinal Products
Approved handling of specially reglemented substances
Our laboratory operates under a valid FAMHP permit for analytical activities with specified hormonal compounds, based on approved agreements (e.g. estrogens, contraceptives), as well as narcotic and psychotropic substances. All work is conducted in accordance with applicable Belgian regulatory requirements, with established controls for authorization, documentation, storage, and traceability.
Authorized for biological agent handling
Anabiotec is authorized for Biosafety level 2+ operations, ensuring the necessary standards for biosafety. Our specialized facilities combine advanced containment infrastructure with rigorous operational protocols, providing a secure environment for your most sensitive biological projects.