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Pace Analytical Life Sciences (PLS) provides senior level, highly experienced scientists dedicated to performing method development and validation services. PLS will work with you to draft a custom validation protocol, provide a thorough report at the conclusion of method development, and deliver a comprehensive report that is ready for regulatory submission once the method validation activity is complete.

Areas of expertise include:

  • Stability-indicating Assays / Impurity Profiles
  • Drug Release / Dissolution / Elution methods
  • Residual Solvents methods
  • Elemental Impurities methods
  • Specific and non-specific cleaning verification / validation methods

PLS will work with you to draft a custom validation protocol or will follow client-supplied protocols to meet your needs and comply with ICH and FDA guidelines. Our protocols are flexible enough to be customized and we work with you to support a phased approach to coincide with your product development timeline. Our experience covers the spectrum of pharmaceutical development phase I, II and III.

Our protocols are customized, but may include the following parameters:

Qualitative Tests:

  • Accuracy (at limit)
  • Specificity
  • Limit of Detection / Limit of Quantization
  • Stability of Standard and Sample (when appropriate)

Quantitative Assays:

  • Instrument / Method Precision
  • Accuracy
  • Linearity / Range
  • Specificity - Matrix Components
  • Specificity - Forced Degradation Studies
  • Method Robustness / Ruggedness
  • Limit of Detection / Limit of Quantization
  • Stability of Standard and Sample Solutions
  • Intermediate Precision

PLS offers method development using a wide range of analytical technologies including: High-performance Liquid Chromatography (HPLC-UV, HPLC-MS, HPLC-MS/MS), Ultra-High-performance Liquid Chromatography (UPLC-UV, UPLC-MS), Gas Chromatography (GC-FID, GC-TCD, GC-MS), Ion Chromatography (IC), Inductively-Coupled Plasma (ICP-MS, ICP-OES), Atomic Absorption Spectroscopy (AA) and others.

We are FDA registered, DEA registered; cGMP compliant, and ISO/IEC 17025 accredited.

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Scope of Services
Pharmaceutical Testing

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