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.