EU QP Responsibilities for Oversight of Product Quality:

Our team of QP's provide QP oversight of our clients' supply chain as per Annex 16 requirements.

Activities requiring an MIA for commercial product:

1)   Batch disposition by a QP: A QP is named on the Manufacturer's and Importer's Authorisation (MIA)  and is responsible for the release of commercial product to the market.

2)   Importation of medicinal products into the EU/EEA (including Biological API or Bulk Drug Product) from a 3rd country.

3)   Analytical retesting of imported finished product into the EU/EEA.

4)   Repackaging or relabeling of medicinal products before distribution in the EU/EEA.

Benefits for you:

  1. Time to market: 2-4 month lead time v typical 9-12 month lead time to develop a PQS and obtain authorisation.
  2. Cost savings: Outsourcing EU quality function (including QP activity) v employing EU Quality team.
  3. 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 compiance.
  4. Measured growth: Ability to size up your European operations following proof of concept.