TGA Sciences, Inc.’s 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
- Use of commercial kits under cGMP guidelines