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EU Distribution

We maintain a strong team of Qualified Persons (QPs) that provide a broad service including site inspections and certification of pharmaceutical batches produced outside of EU.

This capability has enabled PCI to become the preferred partner for many companies in Japan, Australia and USA who value PCI’s knowledge and practical application of EU regulations governing the distribution of investigational and commercial pharmaceutical products.

A full EU distribution service:

  • Importation
  • Analytical testing
  • Late stage optimization
  • QP certification
  • Distribution

Providing an expert service for full European product distribution

  • Warehousing, logistics, analytical testing, packaging and labeling, QP certification
  • Distributing products to patients with expert guidance
  • Clinical, commercial, orphan drugs, investigator lead studies; all under the guidance of PCI’s supply chain professionals and QPs.

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Explore the PCI Process Phase by Phase

PRE-CLINICAL
PHASE I
PHASE II
PHASE III
COMMERCIAL

Swipe to explore the PCI Process

PRE CLINICAL

pre-clinical-icon
  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

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