Clinical supply services

Catalent Pharma Solutions provides a comprehensive, full-service and vertically integrated operation for clinical trials materials preparation in support of Phase I through Phase IV studies, covering virtually all dosage forms. Our clinical supply services are cGMP compliant and include established clinical trial material and material management SOPs with QA oversight.

Our clinical supply services is one of the most respected packaging networks for pharmaceuticals in the clinical trial phase of development. Our team has years of experience and is able to adapt quickly to customer needs, providing innovative, customized solutions. With facilities in the United States, the United Kingdom and Germany, joined by uniform systems and machinery, our increased capacity enables us to handle all your international compliance and distribution needs, ultimately reducing your turnaround time.

To better serve your clinical supply needs, our analytical, clinical manufacturing and clinical supply teams work together to provide a quality, seamless continuum for your product’s path towards market. Our clinical manufacturing team provides technology transfer, over-encapsulation, placebo and other services. Our experienced analytical teams also work closely with packaging to provide quality analytical services within your timelines. Services including microbiological testing, release testing and stability testing, compliment and enhance our clinical manufacturing and clinical supply services.

Overall Capabilities

  • Material logistics
  • Primary packaging
  • Secondary packaging
  • Labeling and assembly
  • Supply chain management
  • Stability packaging
  • Over encapsulation
  • Analytical support
  • DEA schedule I-V licenses
  • Team based project management

Packaging Services

  • Thermoforming
  • Cold forming
  • Multiple product primary packaging
  • In-line printing
  • Vision systems
  • Sachet/pouch
  • Bottle filling
  • Multiple, fully integrated lines
  • Liquid and powder filling
  • Card sealing
  • Rotary sealers
  • Shuttle sealers

Over Encapsulation

  • Comparator procurement
  • Automated equipment
  • Placebo manufacturing
  • 100% check weighing of all capsules
  • Customized fill per your specifications / requirements

Analytical Support Services

  • Microbiological testing
  • Release testing
  • Post package ID
  • Method development / validation
  • Stability testing

Package Engineering and Design Services

  • Comprehensive in-house design and manufacturing
  • Tooling
  • Cards
  • Kits
  • Child-resistant and senior-friendly patented compliance packaging

Labeling and Assembly Services

  • Multi-language labeling
  • Randomization services
  • Open label, double-blinded and unblinding envelopes
  • Manual and automated labeling
  • Patient kit assembly

Warehousing, Distribution and Return Services

  • cGMP warehousing
  • Global distribution and tracking
  • Inventory management system
  • Room temperature, refrigerated and frozen shipments
  • Return drug management

For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.