Bioanalysis & Bioanalytical Services
As constant changes in technology drive 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 (e.g. 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 Research & Development (R&D) and developing a sound, rugged analytical methods that can be reproduced and repeated with consistent and accurate results time and time again.
Keeping almost impossible timelines in mind, the bioanalytical analysis team at BioPharma has also successfully executed the analysis of clinical trial samples to support First-to-File Abbreviated New Drug Application (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.
With successful regulatory inspections spanning global markets, BioPharma can provide reliable, reputable data to support drug submission to multiple agencies for market authorization.
World Health Organization
French – ANSM , Danish – DKMA
Standards Council of Canada
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State of the art facilities. World class leaders. Innovative scientific expertise
As drug potency also increases, driving the need for sensitive methodologies to detect even lower concentrations of drug in biological samples, BioPharma as a bioanalytical CRO company utilizes state-of-the-art LC/MS/MS platforms to meet this need. The scope of bioanalytical services offered at BioPharma include:
- Method feasibility
- Method development (GLP and non-GLP) and validation
- Method transfers
- Bioanalysis of biological samples from BE/BA studies and clinical PK studies
- Bioanalysis to support nonclinical toxicokinetic studies in all animal matrices