At Pharma Medica, our 65,000 square-foot bioanalytical laboratory is housed in our headquarter facility. Our cutting-edge infrastructure includes Electronic Data Capture, multiple platforms of LC-MS/MS systems, several Hamilton robots for automated sample processing, and an on-site Organic Synthesis Lab. Our operations rely on advanced technology for the precise analysis of complex molecules and matrices, leading to a portfolio of over 600 validated bioanalytical assays, including ultra-sensitive assays with Lower Limits of Quantification (LLOQs) in the sub-pg/mL levels.

Research & Development

• Our method development strictly adheres to the principles of Quality by Design (QbD) to ensure the validity and reliability of reported analytical data that will comply with ICH M10 guidelines. We conduct an extensive review of published metabolism to evaluate potential analytical risks and design required experiments using authentic reference standards synthesized onsite to optimize analytical conditions to avoid bias sources, such as back-conversion of metabolites (ex: glucuronide, sulfate, N-oxide) or isomers which may interfere with analytes of interest. Extra measures are taken based on science, experience, and expertise to design and validate robust and reliable analytical methods that will stand the test of time.
• We foster close collaboration with our clients to deliver tailored assay development services. Drawing from our extensive portfolio of complex methods and analytical expertise or developing custom assays that precisely meet unique sponsor needs.