After an intense three month development process, BioPharma Services is excited to report the completion of our 1st bioanalytical, First-to-File bioequivalence project. With increased process efficiencies and reduced lab timelines, we were able to analyze several thousand samples and produce two final reports in less than 48 hours.
Our Bioanalytical Lab, which is GLP certified and has been inspected by FDA, MHRA, Health Canada, EMA (ANSM & DKMA) and ANVISA, is led by Dr. Nicola Hughes, VP of Lab Operations. Dr. Hughes’ 20+ years’ experience in the CRO industry was a major contributor to the success of this project. She praised her team’s dedication saying “This team always produces outstanding work but their commitment and dedication to this project, our sponsor and the company was truly astounding to witness. Our Lab and QA teams worked around the clock to ensure that a successful, quality outcome was achieved. They really went above and beyond”.
“We are exceptionally proud that our amazing Lab Team was able to meet this very challenging target. It proves once again that our planning, organisation and execution strategies are well managed. These process improvements will certainly be beneficial for all future projects” said Anna Taylor, Executive Vice-President of Business Development.
The Lab, and also our 120-bed clinic facility in Columbia, MO are both First-to-File ready. Contact us now to find how we can work together on competitive winning timelines for your project.
We look forward to collaborating with you!
For more information, please contact Ms. Anna Taylor, Executive VP of Business Development at [email protected].