Reliable, comprehensive analytical services

Partner with Patheon, part of Thermo Fisher Scientific, to achieve repeatable high quality and robust process design at every phase of your large and small molecule pharmaceutical development projects with access to a comprehensive array of analytical services.

Flexibility, speed, expertise, and experience are needed to advance your sterile injectable drug products from the preclinical phase to approval. Let us help you transform your discovery into a drug product with the best chance for approval by leveraging:

  • Physical and chemical characterization
  • Preformulation studies
  • Method transfers:
    • Analytical method risk analysis
    • Method validation gap analysis
  • Raw material release testing
  • Drug product release testing
  • Component compatibility testing
  • Product contact part compatibility testing
  • Administration set / giving set compatibility testing
  • Container-closure integrity studies
  • Method development and validation
  • In-process drug product testing
  • Clinical trial material stability testing
  • Cleaning method development and validation
  • Microbiological method development and validation
  • ICH stability testing

Analytical Development Capabilities

We have cGMP labs staffed by highly experienced teams within each of our manufacturing and development sites. From a small quantity of your drug substance or drug product, you can gain the scientifically sound data you need for regulatory submissions and to guide your next steps. We provide high-quality analytical data for high-quality products, processes and business decisions. Key capabilities include:

  • Chromatography: GC, HPLC and UPLC
  • Spectroscopic: UV, FTIR, ICP, and AA
  • Moisture analysis
  • Rheology
  • Particle size analysis
  • Thermal analysis
  • TOC
  • Dissolution analysis
  • Thin layer chromatography

Download our whitepaper, “Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs”