MIAS Licensing Framework & QP Services.

MIAS Pharma Ltd was set up  in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs.

MIAS Pharma delivers two main solutions:

A licensing framework to enable pharmaceutical importation and batch certification (required before each batch of a medicine can be made available in the EU/EEA marketplace)

Qualified Person (QP) services to oversee the release of investigational medicinal product for Clinical Trials and commercial product to the market.

MIAS Pharma can also provide oversight of:

  • European Qualified Person (QP) services
  • Regulatory compliance of manufacturing activities
  • Regulatory compliance of Analytical Testing and Retesting
  • Regulatory compliance of Repackaging / Relabelling services
  • Regulatory compliance of Shipment and Transportation activities
  • Compliance with responsibilities as a Market Authorisation Holder (MAH)


Supporting QP Services & Quality of your products in the marketplace.


The MIAS Advantage

Time to market: 2-4 month lead time v typical 9-12 month lead time to develop a PQS and obtain authorisation.
Cost savings: Outsourcing EU quality function (including QP activity) v employing EU Quality team.
Insights and Expertise: Our CEO is a former senior inspector with the Irish Competent Authority (HPRA) and is considered a Thought Leader in the area of EU GMP and GDP compliance.
Measured growth: Ability to scale up your European operations following proof of concept.