Trust in Excellence and Quality
At ABX, quality is embedded in every stage of the product life cycle. From research- grade materials and lead compounds to finished radiopharmaceutical products, our quality management system ensures that products and services consistently meet customer expectations and applicable regulatory requirements.
Our comprehensive quality management system is designed to ensure the safety, reliability, and consistent quality of all GMP products. It covers the entire value chain - from supplier qualification and raw material procurement through incoming goods inspection, manufacturing, quality control, batch release, storage, and distribution.
Our Quality Assurance teams work closely with Manufacturing, Quality Control, Regulatory Affairs, and Sales. We apply the principles of quality management throughout the product life cycle and comply with GMP, applicable ICH guidelines, and relevant pharmacopoeial and compendial requirements.
We continuously improve our products, processes, and compliance through preventive measures and systematic quality management. Regular internal audits help us monitor performance, identify opportunities for improvement, and maintain high quality standards across all departments.
ABX is committed to meeting applicable German and international regulations, standards, and contractual requirements. We have successfully undergone inspections by the responsible local authorities and the U.S. Food and Drug Administration, as well as regular customer audits. We also conduct ongoing supplier assessments to verify compliance with European and international requirements and to prevent potential non-conformities.
Customer satisfaction and product quality are our highest priorities. Our established complaint management system covers our entire GMP product portfolio and ensures that every quality-related complaint is thoroughly investigated by the responsible departments. Customers are informed ransparently about the results and any resulting actions.
For product quality concerns, please contact: qs-complaints@abx.de
Quality You Can Trust
Our certificates demonstrate our commitment to regulatory compliance, product safety, and consistently high quality. Download our current quality certificates.