Analytical Support
and Regulatory
Know-How™

Our experts understand the ins and outs of complex regulatory approval and registration processes to help you avoid pitfalls and save time and money.

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COMPREHENSIVE VALIDATION SERVICES

Analytical Support and Quality Assurance

Pii analytical laboratories work under strict compliance with cGMP/GLP requirements and base its operations on comprehensive SOPs and rigorous quality assurance practices. Our analytical group has extensive experience in method development and validation with a profound understanding of all aspects of the drug-development process. We design and execute detailed protocols for the full method validation, verification and transfer — covering procedures for active pharmaceutical ingredients and a wide array of drug formulations.

Analytical Testing Capabilities

  • HPLC / UPLC testing with a wide variety of detection capabilities (UV, DAD, RI, CAD, ELSD, ECD)
  • Dissolution Testing (USP Apparatus I, II, III)
  • Particle Size Determination by Laser Diffraction
  • GC / Headspace analysis
  • UV/VIS spectrophotometry
  • FTIR spectroscopy
  • Color spectrophotometry

From Concept to Dosage to Delivery

Critical Quality Assurance

Pii analytical laboratory is designed to perform the following studies in support of all stages of formulation development:

  • Early development stability
  • Excipient compatibility
  • Component compatibility
  • Solubility Screening
  • Thermal cycling and freeze-thaw studies
  • Photostability Studies

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