TGA BioServices, an Absorption Systems company, is a contract research organization (CRO) providing the Pharmaceutical, Biotechnology and Academic communities a comprehensive range of laboratory services in support of basic research and development as well as for clinical studies. We serve clients both in the U.S. and internationally.
We offer the client a complete package of customized testing systems utilized in pre-clinical through Phase IV studies. TGA Sciences, Inc. (FDA/EMA registered and inspected) provides GLP and cGMP regulatory-compliant services for FDA/EMA-level applications and submissions when requested by the client. 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. We specialize in the development and validation of immunoassay systems for the detection of target molecules, antibody responses and quantification in total compliance with QA and cGMP standards.
TGA BioServices also offers in vivo animal studies for the optimization of vaccine immunization schedules, dosing, adjuvant screening, toxicology studies, immunogenicity testing for the release and stability of bulk and finished clinical product, as well as complete antibody development programs.
TGA BioServices now offers the The Endosafe-PTSystem which allows for the analysis of multiple endotoxin samples at a time in as little as 15 minutes. The Endosafe-PTS is a multi-cartridge system developed by Charles River Laboratories that utilizes FDA-licensed disposable cartridges for accurate, convenient endotoxin testing. Three levels of sensitivity are available – 0.01, 0.05 and .005 EU/mL. Volume discounts would apply and analysis can be performed in either GLP / cGMP or as basic R&D readouts. Read more about our Endotoxin Testing services.
Also available is Guinea pig dermal sensitization testing for the identification of contact allergens. All programs are supervised by an in-house Institutional Animal Care and Use Committee (IACUC), while the facility is USDA registered and AAALAC accredited.
Other services provided include FACScan cell labeling studies, Multiplex assays, Bioassay development and validation, tissue culture, sample storage,specimen collection kits with on-site training, data management, protocol generation (SOP), database/statistical analysis and consultation.
TGA BioServices (FDA registered, EMA Certified, AAALAC accredited, DEA licensed and USDA registered) provides GLP and cGMP regulatory-compliant services for FDA/EMA-level applications and submissions as requested by the client. We have a comprehensive Quality System with 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.