Analytical Method Development & Validation

Your pharmaceutical formulations require specialized analytical approaches regardless of complexity. We have extensive experience across diverse dosage forms including tablets, capsules, suspensions, injectables, suppositories, powders, syrups, inhalants, oral liquids, topical formulations, creams, and combination products. Our experts adapt methods to address specific sample matrices, ensuring accurate results for even your most challenging formulations.

We offer a comprehensive suite of analytical tests to support your regulatory submissions and product quality goals:

• API and drug product methods 

• Potency and purity methods 

• Stability-indicating methods 

• Impurity identification and structure elucidation 

• Residuals testing 

• Forced degradation studies 

• Container-closure testing 

• Extractables and leachables 

• Release testing 

• Physical characterization 

• Specification preparation 

We ensure smooth, efficient transfers with standard operating procedures and protocols, using comparative testing or inter-laboratory validation. Our experts can train your receiving site teams and seamlessly transfer existing methods into our laboratories for testing or optimization. Our flexible, phase-appropriate solutions are designed to meet your needs from early development through commercialization:

• GMP analytical method verification 

• Method transfer and optimization 

• Compendial method verification (USP <1226>) 

• Inter-laboratory method validation 

• Stability-indicating method development 

• ICH stability programs 

• Gap analysis and remedial validation 

• Analytical method lifecycle management 

• Reference standard characterization 

• Q1/Q2/Q3 deformulation 

• Drug-excipient compatibility studies 

Our consultative approach 
Partner with our team of regulatory and industry experts who provide more than just testing services. We offer consultative guidance throughout your drug development journey, helping you navigate complex regulatory requirements and analytical challenges. Our flexible, customized solutions adapt to your specific needs, whether you're in early-stage development or preparing for commercial manufacturing. 

What makes analytical method development and validation so important? 
Analytical methods are essential for establishing the identity, potency, physical characteristics, and purity of your pharmaceutical products. To safeguard patient safety and ensure regulatory approval, any methods used in regulatory submissions must be validated to establish accuracy, precision, linearity, specificity, selectivity, limits of detection and quantitation, and robustness. This rigorous validation is required at various stages of the drug development process. 

Our team operates from life sciences testing hubs across the world, providing global access to our expert capabilities. Find your nearest life sciences testing hub on our Locations Page.