Web Flow - Login to access your portal

Clinical Trial Manufacturing

PCI offers a broad range of services to address the manufacturing needs of our clients at each stage of the product lifecycle.

Central to PCI’s international service offering is our capability to manufacture a range of dosage forms in compliance with current GMP standards.

For over 30 years, we have been successfully manufacturing pharmaceutical dosage forms for our international client base. Our strength lies in the integrated nature of our services, combining formulation development and analytical services with clinical trial manufacturing for both potent and non-potent molecules. This comprehensive yet flexible package is delivered with close coordination of each stage of the development process by our experienced project management team. Our facilities have been designed to allow flexibility in processing technology and are

approved for the manufacture of investigational and commercial products. From a handful of capsules for first in-man studies to hundreds of kilogrammes of tablets, we have the technology and capacity to satisfy your clinical trial needs whatever the phase of development.

By combining formulation and analytical testing with GMP clinical trial manufacturing and packaging, we are able to offer a seamless service throughout your development journey.


 

Potent and non-potent Clinical supplies include:

  • Small manual batches
  • API into capsules using Xcelodose® technology
  • Large-scale batches through fully automated technology

Contained Xcelodose® Technology

Recent investments in fully contained Xcelodose® 600S technology continues to demonstrate our market leading position and continued commitment to delivering best in class solutions for potent molecules.

Utilizing our state-of-the-art facilities, PCI has an unrivaled capability to produce solid oral dose forms containing highly potent active pharmaceutical ingredients for both investigational and commercial use.

Leave a Reply

Your email address will not be published. Required fields are marked *

three + three =

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

PCI Points...

You told us what aspects you value as "very important" when choosing a vendor...

Why choose us...

Our global reach and localized support ensures PCI as a strategic partner remains focussed on delivering speed-to-market and the commercial success of our customers

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

Why choose us...