Quality Management System
As soon as a company wants be involved with the manufacture and distribution of medicinal products, it should have appropriate licenses. Regulatory Agencies expect such companies to have a Quality Management System (QMS) in place that assures product safety, identity, strength, purity and quality. Such system should cover all elements that are required for the operations regarding your product. As regulatory requirements evolve and companies change (e.g. by growth, change of products or acquisition), the QMS may require adjustments.
Within Havem there is extensive experience with the design of QMSs and alignment of these with your business processes. Assistance with the application for licenses is also possible.