TSRL’s researchers are experts in oral drug delivery.  Our senior scientists have on average more than 15 years experience in drug development. We work as an extension of our clients’ product development teams, providing preclinical study data to elucidate the underlying mechanism of absorption limitations and offer customized solutions to drug candidates challenged by poor oral absorption.

In addition, TSRL is an established provider of study data needed in support of FDA Biowaiver applications according to the Biopharmaceutics Classification System (BCS), which is an international drug regulation that allows for waiving of clinical bioequivalence (BE) trials for drugs in certain BCS classes. This can translate into substantial development cost savings for both NDA and, in particular, ANDA filings.

We have partnered with a number of other service organizations (i.e. Velesco Pharmaceutical Services, Research Essential Services, MITR) to round out our preclinical services and provide our clients with seamless preclinical development and formulation scale-up services that ensure rapid and smooth execution of IND-enabling studies and initiation of clinical development.