contract services enable you to import and batch release medicinal
products in a compliant manner with no significant investment in licence
application or maintenance activities or office/personnel costs.
MIAS Pharma provides:
Person (QP) services. The Qualified Person is the person defined in
Article 48 of the Directive 2001/83/EC and Article 53 of Directive
2001/82/EC as certifying release of medicinal products for shipment to
market or for use in clinical trials. The primary legal responsibility
of the Qualified Person is to certify batches of medicinal product prior
to use. QP release is also required for medicinal products manufactured
within the EU/EEA for export. In all cases, the Qualified Person is
named on the relevant Manufacturer and Importer Authorisation (MIA). A
manufacturer of finished medicinal products must have at their disposal
the services of at least one Qualified Person.
MIAS Pharma provides oversight of:
compliance of manufacturing activities
compliance of Analytical Testing and Retesting through strategic partnership
compliance of Repackaging / Relabelling services through strategic partnership
compliance of Shipment and Transportation activities through strategic
MIAS Pharma your European Partner
Contact our team today to initiate your European Experience.