Drug Development and Toxicology Planning
Strategic Toxicology Consulting strives to deliver a drug development program that matches your needs whether your company has just identified a series of candidate drugs or whether you are in late stage development where most preclinical studies have been completed and clinical trials are well underway. We can work with your team either remotely or on site and will integrate your needs with those expected by worldwide regulatory agencies.
With access to a wide variety of expertise in preclinical drug development, if we cannot meet your needs, we can put you in contact with someone who does.
STC can design safety studies, have them executed and integrate the results into the necessary regulatory documents to support your clinical trials or market submission.
One of our specialties is justification of drug substance impurities that invariably are found at critical times in the development cycle. We can work with your CMC colleagues to evaluate analytical data to determine whether additional studies may be needed or whether resulting levels can be justified based on literature or existing studies.