With the constant change in technology driving science forward, bioanalysis continues to leap ahead improving the quality, accuracy and speed with which drug analysis in biological fluids is handled. Led by Dr. Nicki Hughes, a 20-year veteran in Bioanalytical Research, the lab team at BioPharma appreciates the importance of delivering quality and innovative solutions to support the drug development programs of our clients. Whether it’s combining the analysis of multiple compounds into a single assay (ie. Dolutegravir/Tenofovir/Lamuvidine) or utilizing a double extraction method to analyze drug products, we find solutions to expedite the turn-around times for analysis with quality and robust assays. This all starts with R&D and developing sound, rugged analytical methods that can be reproduced and repeated with consistent and accurate results time and time again.
With almost impossible timelines in mind, the bioanalytical team at BioPharma has also successfully executed the analysis of clinical trial samples to support First-to-File ANDA submissions to the US FDA. With a turn-around target of a mere 48-hours, the team will work tirelessly around the clock to support our client’s endeavours in an increasingly competitive market place. Given our proven track record of success, let us assess the feasibility of your FTF program so we can be a valuable partner in your future achievements.