Method Development and Validation
Whether you require an assay method, impurity method, targeted leachable method, stability indicating method or a physical property method, Drug Development Solutions has the required expertise and capabilities to be your partner laboratory for method development and validation activities.
Our specialist Senior and Principal Scientists are on hand to understand your requirements and provide a fit-for-purpose solution, whether that be developing a method from scratch, optimising or troubleshooting an existing method. Our Method Development Experts will build in the required flexibility, understanding that the use of the method may evolve as your product moves through the development lifecycle.
Supported by our GMP Quality Assurance team our Method Development Experts, as well as our Scientists, are all proficient and fully aware of the most current regulatory guidelines and requirements for method validation. We will advise and work with you to ensure all methods are sufficiently robust and validated to the required level, taking into account the stage of your product and the end use of the data.
• Raw Materials
• Actives / Drug Substance (Small Molecule)
• Finished Product / Drug product
• Stability Indicating
• Physical Properties
• ICH Q2 (R1) Limit Test Validation
• ICH Q2 (R1) Quantitative Validation
• Fit-For-Purpose Validation
• Method Transfer
• Gap Analysis