FreeThink is a Different Kind of cGMP Partner

In addition to the rigorous process and quality control you expect from typical cGMP work, FreeThink provides clients with pre- and post-cGMP capabilities to de-risk your cGMP study.  This includes expertise in study design, accelerated stability modeling, packaging and comprehensive data analysis.  Known for exceptional customer service and fast study start times, we strive to develop long-term, trusted relationships with our clients that continue beyond a single project.  Here’s what makes us a different kind of cGMP partner:


Pre-cGMP Work to De-Risk Your cGMP Study

At FreeThink, we excel at pre-cGMP work, and leverage this experience to minimize your cGMP stability risk. We believe your cGMP study should never be a test; but instead, a confirmation of already-established criteria. By conducting appropriate pre-work, FreeThink’s leading stability scientists prevent unexpected results and help you to optimize resources and save valuable time by:

  • Developing a robust stability-indicating method or confirming that transferred methods are acceptable.
  • Performing an accelerated stability study using our proprietary ASAPprime® software. This short, four-week study allows us to model results, and assure that the cGMP study outcomes will be successful.
  • Developing a validation protocol suitable to your product’s stage of development.
  • Guiding your selection of appropriate packaging
  • Using matrixing and bracketing techniques to maximize flexibility on packaging choices and get the most value out of your cGMP stability study. This typically results in fewer packaging tests.
  • With information gathered from pre-cGMP work, FreeThink can then confidently design a cGMP study that meets your stability and data requirements and satisfies all regulatory criteria. In short, our consultative approach and thoughtful, deliberate pre-cGMP work will ensure that the cGMP study to follow is as risk-free as possible, and includes stability protocols that:
    • are validated as robust and stability indicative
    • are scientifically justified
    • provide the most value and flexibility for the given amount of work
    • meet all regulatory requirements

Exceptional Customer Service

As our most important customer, we strive to exceed your expectations at every opportunity. We are small enough to be nimble and responsive to your needs. The FreeThink company motto “Yes we can!” reflects our client-centric culture and commitment to excellence, as well as our desire to tackle even the most difficult scientific challenges. In addition, FreeThink's internal systems and processes are designed to maintain client confidentiality from the point of initial consultation to final reports.

Quick Start Times

At FreeThink, our labs aren’t tied up with annual commitment studies. We specialize in conducting cGMP stability work through registration, which allows for fast start times. Boasting some of the quickest start times in the industry, FreeThink can, in most cases, begin your cGMP stability study just days after your samples arrive. We conduct every cGMP study to exacting SOPs and the highest quality standards, but won’t keep your studies waiting in the queue. After all, our goal is to help our client partners develop innovative medicines and products more efficiently, so that safe and effective therapies can reach consumers sooner.

Trust Through Scientific Experience & Quality

You can trust the experienced scientists at FreeThink with your most important projects.

  • FreeThink lead scientists have come to us from the world’s most-recognized global pharmaceutical companies, and most have more than 20 years of experience in pharmaceutical development, including cGMP environments.
  • Our scientists’ industry knowledge and commitment to exacting standards assures that every cGMP study conducted complies with the FreeThink Quality Management System. The focus of this system is strict adherence to modern quality SOPs and risk management approaches to meet or exceed the requirements of the cGMP regulations.
  • We are the scientific experts in stability, committed to advancing the science by leading global stability industry events like the 2016 Science of Stability (SOS) Conference, and conducting breakthrough research studies in stability. See details on the upcoming SOS 2017.
  • We value our client partner associations, and strive to build long-term, trusted relationships that continue beyond a single study. Practicing this approach, FreeThink has already created successful working relationships with many of the top pharmaceutical and biotech companies in the world. To join this distinguished list of satisfied scientific partners, we welcome you to visit our laboratories to discuss our capabilities in-person. To schedule your visit, Request a Meeting, an Audit or a Quote via the Contact Form, or phone us at +860-237-5800 to speak with one of our lead scientists.

Flexible Reporting

Following each cGMP study, detailed reports containing all the generated data are supplied. What makes FreeThink unique are the added benefits we provide including in-depth data analyses and regulatory support through:

  • Examination of the data against expectation, to determine if the results confirm the modeling predictions. Investigations of any unexpected results, or root cause analysis, are conducted.
  • Statistical analyses such as trend analysis, lot-to-lot poolability/consistency
  • Out of Spec (OOS) and Out of Trend (OOT) analyses
  • Regulatory Formatted Data and Submission-Ready Reports
  • Assistance in Quality by Design (QbD) filings using the cGMP results

U.S. Location with Global Reach

FreeThink conducts cGMP Stability Studies from our laboratories in Branford, CT --located midway between New York and Boston along the Connecticut Bioscience Corridor. In most cases, shipments of samples from within the U.S. can be received via overnight delivery. Beyond the U.S., FreeThink has a global reach, with many international clients already partnering with us on their stability projects.

All cGMP study samples and deliveries received at our labs adhere to a strict chain of custody. This documented trail of accountability ensures the physical security of the cGMP samples, data and records. We routinely accept chain of custody deliveries from both domestic and international clients, and have experience working with authorized delivery services and global carriers for imports.

 

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