cGMP Stability Studies

Evaluating the stability of an active pharmaceutical ingredient (API), drug product or nutraceutical against the effects of time, temperature, humidity and light is a vital component of the development process.  Data from these studies are essential for decisions on packaging, and to determine the storage and shelf-life of the product. Likewise, global regulatory authorities and current Good Manufacturing Practice (cGMP) regulations under the U.S. Food and Drug Administration (US FDA) require stability data and analyses at various stages of the product’s development.

 


Overview of cGMP Stability Capabilities

FreeThink Technologies, Inc., a thought leader in the science and technology of stability studies, offers cGMP laboratory stability testing services for all climate zones and accelerated testing requirements in support of regulatory filings.  Experienced in a range of product types, our skilled scientists routinely develop and execute studies for pharmaceuticals, biopharmaceuticals, generic drugs, OTC medicines, cosmetics and nutraceuticals.  We offer our clients a seamless transition from your product's pre-cGMP work to cGMP stability studies through to product launch:

  • Pre-cGMP work to minimize risk before initiating the long-term cGMP study
  • Analytical method development and validation
  • Protocol development
  • cGMP stability testing in support of regulatory filings
  • ICH photostability studies in support of regulatory filings

FreeThink conducts cGMP stability studies with strict adherence to the company’s Quality Management System, assuring data integrity. Our state-of-the-art laboratories offer secure stability suites with fully-trained, experienced scientists so that all cGMP stability studies meet or exceed established technical and regulatory standards.

  • Compliant with US FDA cGMP standards
  • DEA-licensed and registered with the State of CT to handle schedule 1-5 controlled substances
  • Capable of conducting studies with highly sensitizing materials (e.g. β-lactam antibiotics)

De-Risk Your cGMP Stability Study

At FreeThink, we believe your cGMP study should never be a test; but instead, a confirmation of already-established criteria.  In addition to the rigorous process and quality control you expect from typical cGMP work, FreeThink provides extensive pre- and post-cGMP expertise from some of the world’s leading stability experts to help you optimize resources and save valuable time.  We prevent unexpected results through smart science and a thorough understanding of your project. FreeThink is a different kind of cGMP partner, offering:

  • Pre-cGMP work to De-Risk your cGMP study
  • Exceptional customer service
  • Quick start times
  • Trust through scientific experience & quality
  • Flexible reports including summaries, analysis, statistics and raw data
  • U.S. location with global reach