Supply Chain Oversight

Supply Chain Oversight: Product Pathway

Activities requiring an MIA:

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 IMP to a clinical trial.

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.


GMP/ GDP Oversight:

  • Selection of Contract Research Organization (CRO)
  • Quality Management System (QMS) Oversight
  • Oversight of CRO GMP and GDP Activities
  • Issues management – co-ordination between CRO and other parties




Audits and Oversight:

  • API supplier
  • CMOs
  • Packaging and labelling partners
  • Testing
  • Transportation
  • Importation
  • Product Specification File (PSF) development and maintenance
  • Release of IMP to Clinical Trial
  • Complaints and Quality defect Management
  • Coordination between various parties
  • Expiry date extensions
  • Repackaging / relabelling
  • Recall Management
  • Coordination between various parties
  • Expiry date extensions
  • Repackaging / relabelling


 


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 compliance.
  4. Measured growth: Ability to size up your European operations following proof of concept.