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Qualified Persons

Qualified Persons (QPs) play a vital role in bringing products to market within Europe.

Global clients look to the diverse range of skills and specialisms of our highly experienced team of QPs to ensure their clinical studies not only meet the most rigorous standards but also run smoothly, seamlessly and cost effectively.

PCI QPs have earned the highest credentials in accordance with the European Union standards and requirements.

The diversity of experience within our ever-expanding team of Qualified Persons ensures we deal quickly and expertly with specific issues and technical challenges right across the pharmaceutical dosage spectrum, from small molecules to biopharmaceuticals and Advanced Therapeutic Medicinal Products (ATMPs).

Our QPs take responsibility for all stages of the compliance process including the auditing

of manufacturing facilities worldwide to ensure batch manufacture in accordance with GMP.

The team ensure certification of products for use in clinical trials and, for registered products, release to market.At PCI our QPs also offer a consultancy service to ensure that operations are in line with all relevant EU directives and other necessary regulations.

This service extends to CMC advice beginning with requirements for Active Pharmaceutical Ingredients (APIs) and extends through the formulation process, clinical stages and commercial launch of products.

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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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PCI is a global company that focusses on delivering speed-to-market and the commercial success of our customers

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