FDA GLP Expression Analysis

SeqWright provides FDA GLP level expression analysis services within a GLP compliant environment utilizing Affymetrix microarrays and TaqMan qPCR. Our service offering is desinged to provide our customers with high-quality expression analysis services along with all necessary documentation for FDA submissions.

Expression analysis services

Affymetrix microarray (Official Service Provider)
TaqMan qPCR (Official Service Provider)

The systems cited above have relative strengths which lend themselves to certain types of projects. Please contact one of our representatives and provide them with the details of your project so that we may recommend a solution which will achieve your goals in the most efficient manner possible.

Quality Systems

Regulatory Compliance (GLP, CLIA).
Inclusive quality control criteria and standards.
Dedicated Project Director.
Dedicated and customized processes for each project.
Procedure, Equipment and Training Validations.
Advanced automation.
Assay/procedure reproducibility.
Infrastructure and systems that address critical Clinical Trial requirements.

SeqWright is uniquely positioned with the experience, know-how and capacity to deliver secure, timely, accurate and QA reviewed results.

GLP Facility and Operations

State-of-the-art facility specifically designed to maximize quality and process flow, while minimizing potential contamination.

Unidirectional work-flows.
Dedicated clean rooms.
Emergency power for all processes.