FreeThink is a thought leader in the science and technology of stability studies, with some of the most knowledgeable and experienced research scientists in the field.
FreeThink scientists have developed a broad fundamental understanding of how temperature, humidity, oxygen, light and time influence the shelf-life of products. As a result, we are adept at helping customers find appropriate, cost-effective solutions to their stability challenges, including physical changes of active forms, formulations, packaging and storage conditions.
FreeThink is the scientific expert in stability, committed to developing phase-appropriate stability-indicating methods and applying them to your project. We lead the industry in accelerated processes for modeling product shelf-life, obtaining results in just a few weeks using the ASAPprime® stability software we developed. Our team also excels at longer-term traditional studies, such as those based on the ICH guidelines, and cGMP studies that meet all criteria for regulatory filings. In our state-of-the-art labs, stability studies range from quick evaluations to the most challenging in-depth problem solving.
We value our clients, and strive to build long-term, trusted relationships that continue beyond a single study. Through this approach, FreeThink has built trusted, successful working relationships with many of the top pharmaceutical and biotech companies in the world.
Currently, 18 of the world’s 20 largest pharmaceutical companies use FreeThink’s ASAPprime® software, or depend on our laboratory services to help solve some of their most difficult stability challenges. FreeThink routinely partners with both large and small pharmaceutical companies to leverage ASAPprime® studies to speed product development and eliminate unnecessary package screening. Our accelerated studies can typically be completed within six weeks, and predict results with remarkable accuracy. In some cases, ASAPprime® study data has been used in place of traditional long-term ICH studies for regulatory filings. This approach has been successful in many countries, to help speed new drug candidates into the clinic.
FreeThink successfully works with companies to increase the initially granted shelf-life at the time of registration for new products. In fact, one international pharmaceutical company recently reported that it was granted a three-year shelf-life at launch for a new drug product in the EU, using ASAPprime® analysis and just three months of traditional ICH data (with commitment for ongoing monitoring).
FreeThink’s experienced scientists will develop the right stability-indicating analytical method for your project, and provide the quality of data needed for robust regulatory filings in all phases of product development –clinical through registration. To ensure pharmaceutical products meet stability requirements set by global regulatory authorities and the U.S. Food and Drug Administration (US FDA), FreeThink offers stability testing and analyses under the current Good Manufacturing Practice (cGMP) regulations. You’ll find our approach is different than most CROs, however. At FreeThink, we believe your cGMP study should never be a test; but instead, a confirmation of already-established criteria. We prevent unexpected results through smart pre-cGMP science and a thorough understanding of your project.
Learn More About Industry Focus
FreeThink provides biotechnology companies around the world with a full range of laboratory services, and licenses our proprietary accelerated stability software, ASAPprime®.
FreeThink’s experienced scientists play a crucial role in solving some of the most difficult stability challenges faced by the fast-paced biotechnology industry. In addition to formulation development and stability determinations, FreeThink routinely partners with both large and small biotechnology companies to leverage ASAPprime® studies to speed product development and eliminate unnecessary package screening. Our accelerated studies can typically be completed within 6 weeks, and predict results with remarkable accuracy. In some cases, ASAPprime® study data has been used in place of traditional long-term ICH studies for regulatory filings! This approach has been successful in many countries, to help speed new drug candidates into the clinic.
At FreeThink, we can help solve your most complex product development and analysis questions, working with you to fully understand both current and future needs through each phase of the drug development process. Our laboratory scientists are skilled at developing the right stability-indicating methods and degradation product identification for your project, as well as methods appropriate for drug candidate development in all phases –clinical through registration.
To ensure biotechnology products meet stability requirements set by global regulatory authorities and the U.S. Food and Drug Administration (US FDA), FreeThink offers stability testing and analyses under the current Good Manufacturing Practice (cGMP) regulations. You’ll find our approach is different than most CROs, however. At FreeThink, we believe your cGMP study should never be a test; but instead, a confirmation of already-established criteria. We prevent unexpected results through smart pre-cGMP science and a thorough understanding of your project. As a result, FreeThink study results typically provide the high-quality data and analyses needed for robust regulatory filings.
Learn More About Industry FocusFreeThink provides the global generic pharmaceutical industry with a full range of laboratory services, and licenses our proprietary accelerated stability software, ASAPprime®.
FreeThink routinely partners with both large and small generic pharmaceutical companies to leverage ASAPprime® studies to rapidly determine whether a proposed formulation/process matches the originator for stability. Our accelerated studies can typically be completed within 6 weeks, and predict results with remarkable accuracy.
We can also determine, without further testing, the most cost-effective packaging options, since in many cases the originator product is over-packaged. By selecting appropriate packaging, companies can often save a significant amount of money without compromising product quality. This approach is also effective for post-approval changes of packaging, as well as process, excipient source and coating.
FreeThink’s experienced scientists will develop the right stability-indicating analytical method for your project, and provide the quality of data needed for robust regulatory filings in all phases of product development –clinical through registration. To ensure generic products meet stability requirements set by global regulatory authorities and the U.S. Food and Drug Administration (US FDA), FreeThink offers stability testing and analyses under the current Good Manufacturing Practice (cGMP) regulations. You’ll find our approach is different than most CROs, however. At FreeThink, we believe your cGMP study should never be a test; but instead, a confirmation of already-established criteria. We prevent unexpected results through smart pre-cGMP science and a thorough understanding of your project.
Learn More About Industry FocusFreeThink provides the global OTC industry with a full range of laboratory services, and licenses our proprietary accelerated stability software, ASAPprime®.
FreeThink routinely partners with the leading OTC drug companies to leverage ASAPprime® studies to rapidly determine whether a proposed formulation/process has adequate stability. Our accelerated studies can typically be completed within 6 weeks, and predict results with remarkable accuracy.
FreeThink can also successfully develop stability-indicating analytical methods for a host of OTC products. Many labs find this task challenging, since developing stability-indicating methods for OTC products frequently involves a combination of activities which may have compendial methods for the individual scientists, but require development work for the combination. Without further testing, FreeThink can determine the most cost-effective packaging options for your OTC product, allowing for a balance between cost and distribution needs without compromising quality.
FreeThink’s experienced scientists will develop the right stability-indicating analytical method for your project, and provide the quality of data needed for robust regulatory filings in all phases of product development –clinical through registration. To ensure OTC products meet stability requirements set by global regulatory authorities and the U.S. Food and Drug Administration (US FDA), FreeThink offers stability testing and analyses under the current Good Manufacturing Practice (cGMP) regulations. You’ll find our approach is different than most CROs, however. At FreeThink, we believe your cGMP study should never be a test; but instead, a confirmation of already-established criteria. We prevent unexpected results through smart pre-cGMP science and a thorough understanding of your project.
Learn More About Industry FocusFreeThink provides the global consumer and household product industry with a full range of laboratory services, and licenses our proprietary accelerated stability software, ASAPprime®.
FreeThink routinely partners with both large and small companies to leverage ASAPprime® studies to rapidly determine whether a proposed formulation has adequate stability. Our accelerated studies can typically be completed within 6 weeks, and predict results with remarkable accuracy.
FreeThink can successfully develop stability-indicating analytical methods for a host of consumer and household products. Historically, these diverse product types have not generally had good quantitative measurements. For example, FreeThink scientists can quantitatively assess product appearance changes to enable quantitative modeling.
Without further testing, FreeThink can also determine the most cost-effective packaging options for your consumer or household product. By selecting appropriate packaging, companies can balance cost with product distribution needs without compromising quality. This approach is also effective for post-launch changes of packaging, as well as process and ingredient sources.
Learn More About Industry FocusFreeThink provides the global nutraceutical industry with a full range of laboratory services, and licenses our proprietary accelerated stability software, ASAPprime®.
FreeThink routinely partners with both large and small nutraceutical companies to leverage ASAPprime® studies to rapidly determine whether a proposed formulation, process or product has adequate stability. Our accelerated studies can typically be completed within 6 weeks, and predict results with remarkable accuracy. We have had particular success with projects involving vitamins.
FreeThink can successfully develop stability-indicating analytical methods for a host of nutraceutical products. Many labs find this task challenging, since developing stability-indicating methods for nutraceuticals frequently involves a combination of activities which may have compendial methods for the individual scientist, but require development work for the combination.
Without further testing, FreeThink can determine the most cost-effective packaging options for your nutraceutical product, allowing for a balance between cost and distribution needs without compromising quality. This approach is also effective for post-launch changes of packaging, as well as process and ingredient sources.
Learn More About Industry Focus
