Pace Analytical Life Sciences has a department of senior level scientists that is dedicated to performing method development and ICH method validation services. Our scientists have years of experience working on stability indicating methods, residual solvent methods, dissolution methods and specific and non-specific cleaning validation methods. We have our own protocols that comply with ICH and FDA guidelines or we can follow client-supplied protocols. Our protocols are flexible enough to be custom designed to meet client specific requirements. Our analytical development services include both pharmaceutical method development services as well as method development services for medical devices. We also offer USP method validation services.
Pace Analytical Life Sciences offers method development and validation services using a wide range of technologies including LC/MS/MS, LC/MS, UPLC, HPLC, GC/MS, GC, IC, ICP and AA. We have extensive experience in HPLC method development, HPLC validation, GC method development and GC validation. We use these analytical techniques to develop and validate methods for API’s, intermediates, raw materials and finished products.
We provide a report at the conclusion of each project. Included within this report is the analytical method itself which is written in a step-by-step format.
Our protocol includes the following parameters:
Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their analytical method development and validation projects are successfully executed. Our experience covers the spectrum of pharmaceutical development phase I, II and II.
We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.
Contact us to discuss your testing needs. 651-738-2728 Email Us