TGA BioServices’ experience in Quality Assurance ensures a total understanding of Good Laboratory Practice (GLP) and Current Good Manufacturing Practices (cGMP) that our clients can utilize from pre-clinical through Phase IV clinical studies. We offer dedicated QA/QC personnel to insure compliance to required guidelines. There is an additional charge for GLP and cGMP methods as compared to R&D projects.
With our efficient sample handling procedures and rapid turnaround time, we provide a high quality professional service that is precise, reliable and confidential.
Specimen coding (manual or barcode) to provide immediate access and tracking throughout the sponsor’s clinical study
Sample storage includes validated, temperature sensitive chambers that are in complete compliance with cGMP guidelines
Sample preparation techniques developed in response to the client’s requirements for a precise and accurate analysis
Clinical sample handling and analysis are performed in accordance with cGMP guidelines, including in-house or sponsor documented assay SOP’s, for the development of products in compliance with FDA guidelines
In-house Quality Assurance documentation system
The in-depth experience and cGMP training of our analysts ensure that all analysis are performed in a professional manner