The projects ranged from method validation and stability studies, cross-validation of other external labs, support for investigator sponsored studies, Clinical Phase I to Phase IV studies (including pivotal BE studies). Our last major study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers were to be analyzed within a very short time frame. This study – and all other studies – were done according to a very high quality and reporting standard and with a high responsiveness. We have audited the Lab in 2004 by our BHC GLP QAU and in 2006 by a BHC GLP trained bioanalytical expert, in both cases without major findings.

We have worked with NorthEast Biolab on several programs and have found them to be professional, collaborative and responsive. As a small company, our vendors are key members of our project teams. The scientists at NorthEast Biolab are technical experts, who produce high quality data, on-time and on-budget. They also provided critical insight into data analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend NothEast Biolab and look forward to working with them in the future.

I have worked with a number of companies (large and small) over the years and NorthEast Biolab is by far the most responsive and thorough service provider. In an industry where a vast majority of businesses establish practices that remain rigid, NorthEast Biolab works closely with the client to provide the most efficient and cost-effective approach to getting the job done. The integrity of the scientific staff is as refreshing as their willingness to provide ingenious scientific input and high-quality data. They truly go that extra mile to make the collaborations successful and I will continue to enjoy very productive interactions with them in the future.