EU MAH, MIA, QP & QC SERVICES

  • MAH in EU
    • Complete services in accordance with EU legislation related to MAH duties - MAA submissions and procedures, MAA procedure maintenance, communication with the authorities, MA holding after MAs are granted, PV services, RA services, recalls, ect. Details are described in relevant sections of Services
    • BT (Batch testing in contracted EU accredited QC laboratory), and Batch Release by own employed EU QP are included in package of services offered
  • MIA in EU - QP Services (API audits), EU Batch Release (BR) Site,
    • Manufacturing and Importation Authorization – licensed in Cyprus, valid for EU
    • Authorized Batch Release site in EU - experienced and well-trained Qualified Persons (QP) responsible for ensuring that each individual batch has been manufactured and checked to be in compliance with EU regulations, marketing authorization (MA) and Good Manufacturing Practice (GMP), in order to support marketing authorization holder (MAH) in its main responsibility – to assure performance of a medicinal product over its lifetime.
    • Provision of contract QP services in compliance with EU Directives for the manufacture and release of finished pharmaceuticals and GMP Directive and guidelines
    • Issuing EU QPD (QP Declarations) for APIs
    • QP audits of manufacturing sites for APIs and intermediates
    • Licensed for import of medicines in Cyprus
  • Batch Testing (BT) Site in EU (with contracted QC laboratories)
    • Approved and accredited, contracted QC testing laboratory with wide range of analytical technologies, that could offer complete chemical and microbiology testing services according to EU regulations.