Quality Management:
Pharmaceutical Quality Assurance & Control Systems
Aenova's Quality Management
At Aenova, we ensure the highest standards of quality, safety, and compliance through a rigorous pharmaceutical quality management system (QMS). With the most diligent pharmaceutical quality assurance system in place and a full set of control measures, we guarantee strict adherence to regulatory requirements at every production stage.
Our commitment to quality management is built on a robust set of standards, processes, and performance measures designed to ensure the highest production quality is deployed in all our manufacturing sites. We adhere to ICH Q8, Q9, and Q10 guidelines, providing a comprehensive framework for pharmaceutical development, risk management, and lifecycle management.
Our internal quality management system promotes excellence by focusing on continuous monitoring, proactive compliance, and the harmonization and standardization of practices across all operations.
Our robust quality processes focus on product integrity, critical quality attributes, and continuous improvement to meet global standards. We adhere to a broad variety of international guidelines and regulations (EU, FDA, WHO, and others) for both human and animal health, providing a comprehensive framework of Quality Assurance during the full product lifecycle.
We leverage digitization to enhance efficiency and accuracy, backed by a highly qualified team dedicated to ongoing maintenance of our facilities and equipment, as well as rigorous validation of our equipment, software, processes and methods.
Our Quality & Regulatory Approvals
Our manufacturing sites hold a range of prestigious regulatory approvals and have an outstanding track record of successful inspections by health authorities (for human and veterinary scope).
13 out of our 14 sites have EU-GMP certification, 10 out of 14 sites are approved by the U.S. FDA, and we hold EAEU approval for 11 out of 14 sites. This allows Aenova to serve the largest pharmaceutical markets in the world.
Beyond these major certifications, our sites are also accredited by a wide range of other key regulatory bodies, including Swissmedic, ANVISA, GCC, NMPA, KFDA and PMDA, among others.
Our CDMO Manufacturing Services
Quality assurance at Aenova covers a wide range of leading contract manufacturing services to meet the diverse needs of the pharmaceutical industry. Aenova's manufacturing services offer includes the production of high-quality technologies: sterile for injectable products, solids forms (tablets and capsules) including high potent drugs (until OEB 5), semi-solids forms (creams, gels, and ointments, suppositories, soft gel capsules and gummies) for pharmaceutical and dietary supplement markets.
As part of our manufacturing services, Aenova also offers quality control services (analytical and microbiological controls) to show evidence of the purity of your manufactured products from development phase to commercial release and during all their shelf life. Aenova provides a wide range of packaging services, too, to enhance your market appeal.
All these services are handled at Aenova ensuring that your products are securely manufactured, analysed and packaged to meet global regulatory standards according to your needs.
Why Aenova's Quality System Matters
Whether you partner with Aenova for development or manufacturing, our robust quality system comes as standard. With rigorous testing protocols and powerful quality assurance, regulatory expertise is fully integrated into every stage of your product’s lifecycle to guarantee your products meet the highest standards for quality and compliance - reliably, and without compromise.
Contact Us
Contact us today to learn more about our pharmaceutical quality management system and how we can help ensure compliance, safety, and excellence across your manufacturing processes.
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