Confidence Beyond Compliance

PharmaLex has a recognized and innovative expertise in the development, validation and control of analytical procedures and bioassays. We have been a pioneer in applying the Quality by Design (QbD) and LifeCycle thinking to analytical procedures and bioassays with a vision: achieving confidence and compliance. Our team is composed of chemists, biologists and pharmacists that are able to provide the most advanced statistical support to ensure your analytical procedures and bioassays are reliable and compliant. Our scientific and quality team can also provide you with the automated analyses tools to need to maximize your productivity in accordance with regulations. Finally we also have a tremendous expertise in PAT procedure development and validation.

Our services include:

Bioassays

  • Expertise in a wide range of bioassays (ELISA, qPCR, FACS, MNA, …)
  • Development by means of DoE
  • Optimization for precision and range
  • Strategies and methods for parallelism evaluation
  • Advanced signal processing, multiplex assays
  • Non-linear modeling
  • Format optimization and justification
  • Evaluation of capability and uncertainty
  • Control strategy and transfer

Analytical procedures

  • Modeling of wide range of procedures (HPLC, MS, NIR, RAMAN, ….)
  • Development by means of DoE
  • Optimization of procedures by means of advanced modeling
  • Advanced signal processing (UV, NIR, MIR, RAMAN)
  • Validation of PAT procedures NIR and RAMAN based
  • Format optimization and justification
  • Evaluation of capability and uncertainty
  • Control strategy