GLP Bioanalysis

GLP Bioanalysis

Automated technologies for high-throughput LC/MS/MS and GC/MS/MS analyses permit Tandem Labs to support large, as well as small projects, that require rapid attention.

Criteria for acceptability of an assay are stringently adhered to in accordance with Tandem Labs' SOPs and the FDA's Guidance for Industry for Bioanalytical Method Validation, Section VI, Application of Validated Method to Routine Drug Analysis.

To view the FDA guidances, click below:

http://www.fda.gov/cder/guidance/4252fnl.pdf

21 CFR Part 58 Good Laboratory Practices: Guidance for Industry Bioanalytical Method Validation

http://www.cfsan.fda.gov/~dms/opa-pt58.html