Analytical Method Development and Validation Supporting Drug Development
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Our highly skilled method development scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure that the method will be 'fit for purpose' for APIs, raw materials, excipients, drug products or packaging. Our expertise spans a variety of molecules and formulations that include small molecules, biologics, nanoparticles, solids, patches, gels, ointments, liquids and inhaled products. Intertek’s laboratories are equipped with sophisticated analytical technologies including chromatography, mass spectrometry, elemental analysis and spectroscopy. Our teams are experienced with sample preparation techniques which may include procedures for trace levels of analysis and approaches suitable to the physical and chemical properties of the matrix and the dosage form.
Method Validation Contract Services
By working with Intertek, you gain an experienced partner with a good working knowledge of method validation requirements suitable for different phases of development. To ensure methods meet regulatory requirements we follow relevant ICH guidelines such as ICH Q2 (R1) or Pharmacopoeial methods/compendia guidance in combination with client-specific protocols.
Analytical Method Lifecycle Management
Your method validation requirements and analytical methods will most likely evolve over the commercial lifecycle, from early-stage development through to commercial use. Our strengths in assessing existing method validation, identifying gaps and validation remediation or improvement planning are coupled with vast method optimization experience for many sample types, helping to ensure a successful validation.
Find out more: https://www.intertek.com/pharmaceutical/analysis/method-development-validation/
