Method Development and Validation

Analytical method development and validation that is phase-appropriate across a range of techniques supporting pharmaceutical product development

Analytical method development and validation is critical to achieving the reliable analytical data you need to support your pharmaceutical development activities. Method development and validation can be costly and labour intensive. Considerable knowledge, and experience coupled with advanced instrumentation, is critical to develop efficient, accurate, reliable and robust analytical methods.
 
Method development
Our highly skilled method development scientists have acquired years of experience, working across many types of product, methods and analytical technologies to ensure that the method will be 'fit for purpose'. 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
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 compendia guidance in combination with client-specific protocols.
 
Method Lifecycle Management
Your method validation requirements and analytical methods will most likely evolve over the commercial lifecycle, from early stage development through 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.

Global method development and validation expertise
Our method development and validation teams are located in the US, Europe, India and Australia where our facilities utilize a wide range of analytical technology to meet your specific analytical needs.
 
Supporting your analytical method lifecycle
Intertek offers cost effective strategic approaches to analytical method lifecycle management, which combines method development, improvement, qualification, validation, transfer, and maintenance related to GMP production.  Our integrated approach to analytical method lifecycle has been deployed in thousands of projects for clients around the world to ensure that their methods are best suited for the intended use at the various clinical stages on the way to commercialization. With Intertek as your outsourcing partner, you can concentrate on your core activities whilst our strategic approach to method development and validation brings time and cost savings.
 
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
AMER
+1 908 534 4445 x600
EMEA UK:
+44 161 721 5247
Switzerland:
+41 61 686 4800