Analytical Method Development and Validation Supporting Drug Development
Pharmaceutical analytical method development and validation laboratory services supporting drug development enabling regulatory-driven and phase-appropriate methodology from our global analytical GXP laboratory network
Pharmaceutical method development and validation can be complex, costly and labour-intensive. A good understanding of current regulatory expectations and relevant chemistries coupled with advanced instrumentation is critical to developing efficient, accurate, reliable analytical methods. Furthermore, regulatory-led and phase-appropriate methodology enables you to achieve the reliable analytical data you need to reach your next development milestone.
Analytical Method Development Expertise
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.
Supporting Your Analytical Method Lifecycle
Intertek offers cost-effective strategic approaches to analytical method lifecycle management, which combines method development, improvement, qualification, validation, method transfer to and from client laboratories, 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.
Your Method Development and Validation Partner
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. 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. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
Good Manufacturing Practice (cGMP) Services
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Salem Industrial Park
Whitehouse, NJ 08888
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