ANALYTICAL DEVELOPMENT
& VALIDATION
Proven expertise applying rigorous standards
ANALYTICAL DEVELOPMENT
& VALIDATION
Proven expertise applying rigorous standards
Feasibility
At Boston Analytical, we perform feasibility of new or revised test methods to ensure the equipment and facilities at Boston Analytical are appropriate for transferring or performing analytical methods on pharmaceutical products.
Optimization
Boston Analytical’s scientific team applies their experience to the design and execution of enhancement of complex methodologies.
Development
After over 30 years of developing cGMP analytical methods, Boston Analytical has the skills, experience, and equipment to expertly develop the test methods for product characterization.
Validation
Boston Analytical validates methods under cGMP, following USP and ICH guidelines. We test the performance characteristics, such as specificity, precision, and accuracy, that your method requires and then produce a detailed validation report.
Troubleshooting
Leverage Boston Analytical’s range of scientific experience and modern instrumentation to find answers to analytical method issues.
Method Transfer
Method transfer in the pharmaceutical industry is a crucial element of the quality control aspect of the drug development process.