Bioanalysis & Bioanalytical Services

State-of-the-Art Bioanalytical Services

The development of high-quality and cost-effective solutions for bioanalysis is critical for the success of drug development programs.^[i] Moreover, with the rapid progress of pharmaceutical research, the requirements regarding the sensitivity, speed, accuracy, and cost efficiency of bioanalytical techniques are increasing.^[ii] BioPharma Services Inc.’s expert bioanalytical team and in-house laboratory offer our clients a comprehensive range of state-of-the-art bioanalytical services. The scope of our services includes:

• Method feasibility studies
• Method development (GLP and non-GLP) and validation
• Method transfer
• Bioanalysis of biological samples from bioequivalence/bioavailability and clinical pharmacokinetic studies
• Bioanalysis to support nonclinical toxicokinetic studies in all animal matrices

Innovative, Robust, and Reliable Bioanalytical Solutions

Our expert bioanalytical team develops novel techniques for the analysis of drug products, including combination analysis of multiple compounds into a single assay (e.g., dolutegravir/tenofovir/lamivudine) or utilization of a double extraction method. The analytical methods established by our team are robust, reproducible, and yield consistent and accurate results.

Expert Bioanalytical Team

BioPharma’s bioanalytical team includes accomplished pharmacologists and bioanalytical scientists who rely on innovative strategies to meet the complex drug development needs of our clients. The team is led by Dr. Nicki Hughes, a veteran with 20-year experience in bioanalytical research. Dr. Hughes oversees the R&D, validation, and production groups and sets higher-than-industry standards to ensure smooth laboratory operations.

Under her leadership, the bioanalytical team has achieved over 98% passing batch rate of our studies. Moreover, the team continuously develops novel LC-MS/MS-based assays to support nonclinical and clinical trials, including studies with atypical routes for drug administration and sample collection. In addition to their professional accomplishments, BioPharma’s bioanalytical scientists distinguish themselves by their enthusiasm and commitment to the highest study quality.

Recognized Worldwide Expert Regulatory Support

BioPharma has undergone successful regulatory inspections across global markets and can provide reliable, reputable data to support drug submissions for market authorization to multiple agencies. Thus, our bioanalytical team has extensive experience in the analysis of clinical trial samples to support First-to-File Abbreviated New Drug Application (ANDA) submissions to the U.S. Food and Drug Administration (FDA).

BioPharma Services can reliably and cost-efficiently analyze clinical trial samples to support our clients’ submissions to the FDA, Health Canada, European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Brazilian National Health Surveillance Agency (ANVISA), World Health Organization, French National Agency for the Safety of Medicines and Health Products (ANSM), Danish Medicines Agency (DKMA), and Standards Council of Canada.

In-house Bioanalytical Laboratory 

The development of novel drugs with high potency has driven the need for ultrasensitive techniques to detect low drug concentrations in biological samples. BioPharma’s in-house bioanalytical laboratory team utilizes a state-of-the-art liquid chromatography with a tandem mass spectrometry (LC/MS/MS) platform in to perform highly sensitive and accurate analyses in a variety of matrices.

Client-centered Approach with Expedited Turnaround Times 

Our team focuses on the specific needs of our clients’ drug development programs to develop a comprehensive and efficient strategy for bioanalysis. Our target turn-around time for bioanalysis is merely 48 hours, and our talented bioanalytical team works tirelessly to support our clients’ endeavors in an increasingly competitive marketplace.

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