Sample Handling and Storage

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TGA Sciences, Inc.?s experience in Quality Assurance ensures a total understanding of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) that our clients can utilize from pre-clinical through Phase IV clinical studies. 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

About TGA Sciences

TGA Sciences, Inc. is a contract research organization (CRO) that provides its Pharmaceutical, Biotechnology and Academic clients a comprehensive range of laboratory services in support of basic research and development as well as for clinical studies. We offer a complete package of customized testing systems utilized in pre-clinical through Phase IV studies, including custom assay development, in vivo animal studies, cell-based assays, various immunological-based testing, as well as sample storage. We serve clients both in the U.S. and internationally.

All of our services are in compliance with cGLP and cGMP requirements. We are FDA registered, EMA Certified, AAALAC accredited, DEA licensed and USDA registered, and we have a comprehensive Quality System with a dedicated QA/QC Director to ensure that internal, customer and regulatory requirements are met.

To learn more about our services, request a quote or schedule an audit, please contact us using the form on the left, or contact Michael Settles at msettles@tgasciences.com or 781-393-6910 x203.