DRUG DEVELOPMENT SERVICES

We understand what it is like to be surrounded by regulations, obscure requirements and sometimes confusing communications. We know that your goal is to have the regulatory agencies license your product as quickly and efficiently as the demands for safety and efficacy allow. We want to work with you to help minimize the amount of non-clinical safety pharmacology, toxicology, pharmacokinetic, reproductive and genetic toxicology information you need to progress rapidly into the IND phase for your product. We want to try to anticipate any clinical toxicities to minimize unwanted surprises in Phase 1. We can help you correlate Phase 1 clinical results with non-clinical results to support your therapies safety and efficacy profile. We want to be there early in the vital End-of-Phase 2 meeting preparation so that you will know exactly what non-clinical studies you will need to do concurrently during Phase 3 clinical development and we want to minimize those requirements where possible...