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Analytical Support
and Regulatory

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



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

Talk to a Pii Scientist