At A-REG, we understand that quality is a cornerstone of the pharmaceutical industry. Our comprehensive quality consultancy services cover aspects of quality control, from testing materials during manufacturing to the final product. This broad area of analytical methods and testing is deeply interconnected with regulatory affairs as well as quality assurance.
Quality assurance focuses on ensuring that manufacturing, testing, and product release processes are established with robust controls in accordance with Good Manufacturing Practices (GMP) and clearly defined guidelines. We recognise the specific requirements for certain products, such as vaccines, which require batch testing at an Official Medicinal Control Laboratory (OMCL), and the intricate process of batch release for any product.
Our expertise lies in supporting all these areas, especially at the intersection of regulatory and quality. This also includes official communication with health authorities or OMCLs, GMP inspection preparations, and/or supporting inspections themselves (including GMP inspection information management in IRIS). We are dedicated to helping our clients navigate the complexities of quality and regulatory requirements, ensuring their products meet the highest standards.