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Integrated Analytical Solutions, Inc. is a proud member of Genesis Drug Discovery & Development (GD3), a fully integrated CRO providing services to support drug discovery programs of our clients from target discovery through IND filing and managing Phase I-III clinical trials.
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Validation Track
GLP Bioanalysis
Ensuring a method performs according to established criteria with each set of test samples is of paramount importance for data intended for regulatory submission. At this stage of development, bioanalytical method validation and test sample analysis will be under the control of our Quality Assurance Unit. Bioanalytical methods are validated according to EMEA/FDA guidance and your test samples are analyzed according to the FDA GLP regulations and IAS Standard Operating Procedures (SOPs).
Full support for test samples from the following studies:
- Discovery PK studies
- Cassette PK studies
- Biomarker Studies
- Toxicokinetic studies
- Pharmacology studies
- Clinical studies (Phase I-IV)
- Tissue distribution studies
- Drug-drug interaction studies
- BA/BE studies
