We are an FDA-inspected Pharmaceutical Research Institute founded by world-renowned experts Dr. Kamal Midha and Dr. Gordon McKay.

We have the experience, expertise, and tools to optimize the entire pharmaceutical cycle, from concept to approved product and all points in between. In fact, our team has “set the bar” in several cases for innovator and generic product regulatory requirements.

We are large enough to efficiently deliver on both pilot and pivotal studies, yet small and flexible enough to function as an extension of your research team for analysis and formulation/product development.

Pharmalytics specializes in LC/MS/MS method development, validation and application.  The members of our team are experts at measuring to extremely low concentrations (1pg/mL or less) of drug substance in various matrices. A proprietary list of fully validated bioanalytical methods is available for review by clients. 

Pharmalytics also designs and writes supporting clinical protocols to assess bioequivalence. This includes conduct of pilot studies, determination of descriptive pharmacokinetics and planning and implementing study designs for pivotal studies with the appropriate dosing strategies, power and evaluation of dosage forms that give the highest likelihood of achieving bioequivalence. 

The combined expertise of highly trained research analysts, quality assurance officers, project managers, biostatisticians, report writers, and information technology officers, all lead by the principal investigators, has made Pharmalytics the premiere institute to conduct difficult bio-studies. 

Pharmalytics has been inspected by the USFDA on numerous occasions. What's more, Dr. Midha and Dr. McKay have had their opinions on various bioanalytical practices sought by regulatory agencies and industry throughout the world.