Excite Pharma Services offers method development, validation and transfer services for drug substances (APIs), drug products, related substances, impurities and biological matrices to supplement IND and NDA submissions. We utilize both the US Pharmacopeial Convention’s “Validation of Compendial Procedures” guideline (USP 1225) and the ICH Q2 (R1) Methodology for Analytical Validation. For bioanalytical method validations, we employ the FDA’s Bioanalytical Method Validation Guidance for Industry.
Excite Pharma Services recognizes that depending on your stage of development, full method validation may not be required. We do offer abbreviated services for method verification when full validation is unnecessary. We also recognize that clients may have varying degrees of development already completed which is always taken under close advisement when evaluating a project and the associated costs.
Excite Pharma Services’ staff have developed and validated hundreds of analytical methods. They have also transferred methods to clients around the world.
For a full list of our in-house equipment, please click here.
If you have any questions or are interested in more details of our method development / validation capabilities, please contact us.