Quality

To ensure quality and compliance are never compromised, uniform systems are integrated throughout every level of our organization.

Our quality management system consists of a comprehensive set of Standard Operating Procedures written to comply with provisions of applicable Food and Drug Administration (FDA), Good Laboratory Practice (GLP) regulations, and other global agencies. Alturas Analytics, Inc. has laboratory-wide quality control (QC) and quality assurance (QA) procedures designed to assess and monitor the ongoing integrity of the testing performed in its facilities.

Applicable Code of Federal Regulations (CFR) includes:

FDA GLP for Nonclinical Laboratory Studies, 21 CFR Part 58
FDA Electronic Records Electronic Signatures, 21 CFR Part 11

Speak with an Expert

Dave Schumacher, RQAP-GLP

Quality Assurance Director

With over 20 years in Quality Assurance, David Schumacher, RQAP-GLP since 2004, oversees the Alturas Analytics Quality Assurance Program. David is an experienced Quality Assurance Professional in FDA regulated environments and auditor in numerous analytical techniques. His emphasis is in bioanalytical (LC−MS/MS and ligand binding) and formulation assays.

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To ensure quality and compliance are never compromised, uniform systems are integrated throughout every level of our organization.

Speak with an Expert

Dave Schumacher, RQAP-GLP

Quality Assurance Director

PBSS Workshop – Human PK and Dose Prediction for Small Molecules

PBSS Symposium | Applied Pharmaceutical Analysis | Presentation

Welcome Maggie McMullen as Chief Business Development Officer

PBSS Workshop: September 8

We’ll See You in Boston!

PBSS Workshop: Human PK and Dose Prediction for Small Molecules

AAPS 2023 PharmSci 360

PBSS Workshop: ADME/DMPK Studies for IND and NDA Filing for Small Molecules: Nuts, Bolts and Best Practices