Sample Handling and Storage

lab-workers-2TGA 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