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Batch testing

Our services

  • Analytical testing of all materials and products
  • T0 for stability studies
  • Customised testing
    • following methods transferred to our laboratories
    • following methods developed and validated by Quality Assistance
  • Compendial testing
    • in accordance with Ph. Eur., USP-NF and JP
  • Retained samples
    • back-up storage facilities for your retained samples, an integral part of your disaster recovery programme

Wide expertise

  • Over 30 years in NCEs
  • Over 15 years in Biologics
  • All laboratories on one site
  • Comprehensive range of physicochemical,biological and microbiological testing: general quality, identification, assays,potency, limit tests, impurities, microbial examination, physical testing (e.g.disintegration, dissolution) and packaging
  • Hundreds of QC samples tested annually

All matrices

  • Drug substances
  • Drug products
  • Starting materials
  • Excipients
  • Packaging materials

Analysis and reporting

  • Analyses carried out in our laboratories according to pre-defined specifications
  • OOS-OOT procedure compliant with FDA requirements (Full Scale Investigation, Reportable Values)
  • Certificates of Analysis approved by a Qualified Person

Communication

  • A dedicated team in close contact with you, dealing with your project efficiently and helping you to meet your objectives

Quality Assurance

  • cGMP certified
  • FDA inspected
  • PMDA inspected
  • ANVISA inspected


You can download the brochure
batch-testing-quality-assistance

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