What We Offer

Analytical methods are developed in consultation with the client and are specific to the stage of work. This can range from a simple assay-only method for very early R&D work to a fully validated, phase-appropriate related substances method for clinical trial or commercial batches.

Our group provides services designed to meet the needs of our clients during various stages of drug development, including:

Method Development/Implementation

Method Validation

Study Sample Analysis

Forced Degradation

Scientist performing analytical testing using microscopy for topical and transdermal drug products

Analytical Strategy

  • Phase-Appropriate Method Design: Methods aligned to development stage—from early feasibility to stability-indicating approaches for clinical and commercial programs.
  • End-to-End Method Support: Development through validation to ensure reliable, reproducible, and compliant methods (ICH, USP, FDA, EMA).
  • Characterization & Stability Insights: Impurity profiling and forced degradation to understand degradation pathways to support specifications and shelf-life.

Regulatory Guidance

  • The MedPharm analytical team operates under ICH Q2 (R2) guidance for the validation of analytical procedures.
  • This guidance provides the framework for all analytical work, including R&D development.
  • It ensures each stage of work flows smoothly into the next, avoiding unnecessary repetition and supporting the development of phase-appropriate methods.

Our Instrumentation

Our group uses HPLC, UHPLC, and GC to analyze a wide range of analytes and provide accurate, high-quality data which is then used to characterize formulations from R&D through to commercial release.

HPLC / UHPLC GC
Shimadzu i-Series Shimadzu GC2010
Shimadzu Nexera Agilent 8890
Agilent 1200 / 1260 / 1290 Agilent 7690B
Waters Alliance 2695 and ARC Agilent 7697A Headspace
Detectors: DAD, ELSD, PDA, RI, UV, VWD, FLD Detectors: TCD and FID
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