Good Laboratory Practices (GLP) help ensure data is traceable, repeatable, and your product is safe and effective, ensuring your development dollars are well spent. Experiments are less likely to be repeated, and data will better withstand the scrutiny of FDA reviewers during 510(k) submission.
Are you in need of pre-clinical characterization studies?
As part of your FDA 510(k) submission for your product, it must include a pre-clinical analytical bench report performed under conditions in which laboratory studies are planned, performed, monitored, recorded and reported. We can help identify the necessary studies and carry them out with data and reports in compliance with GLP guidelines.
- Limit of Detection
- Stability (real-time and accelerated)
- Interfering Substances
- Repeatability (intra/inter assay variability)
Does your research require GLP?
GLP practices are becoming the standard in research and development to promote the quality and validity of test data. Don’t get left behind. We provide the required traceability, organization, processes and facility conditions for GLP work if your project requires it.
InfinixBio works with Entrepreneurs, Biotechnology Companies, Biotech Incubators, and Investors to advance technology from concept to reality, making your product work better, or adapting your product to meet unmet or even unarticulated market needs. As a collaborative partner, our goal is making your product prosper.
In an ever-challenging marketplace, different situations call for flexible solutions and InfinixBio can provide the personnel and tools you need to succeed!
The InfinixBio team of experienced scientists provides deep domain expertise in genes, proteins, and cells that delivers creative solutions to a variety of difficult problems in Biotechnology product development. We have locations in Columbus and Athens Ohio with over 25 scientists (27% PhDs) operating in our labs.