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 preclinical through Phase IV studies. TGA BioServices (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. TGA BioServices specializes in the development and validation of immunoassay systems for the detection of target molecules, antibody responses, and quantification.

TGA BioServices has 16,000 ft2 of laboratory space, comprised of five separate labs:

  • Analytical
  • Immunochemistry
  • Bioassay
  • R&D
  • Animal Facilities

Facility Credentials:

  • AAALAC-accredited facility for in vivo animal studies
  • USDA registered
  • OLAW certified
  • In-house IACUC committee

We use validated laboratory computer systems in compliance with 21 CFR Part 11. All of our critical use equipment is calibrated and validated. All critical systems can be run off of our backup generator.

We are located just outside of Boston, offering easy access from major clinical trial sites and centers in Cambridge and Greater Boston.

Accreditations:

  • U.S. Department of Agriculture
  • Drug Enforcement Administration – State and Federal DEA Licensed
  • U.S. Food and Drug Administration
  • Association for Assessment and Accreditation of Laboratory Animal Care International
  • Office of Laboratory Animal Welfare Registration
  • Medicines and Healthcare products Regulatory Agency Inspected
TGA BioServices