Pharmaceutical companies, whether established or startup, have a daunting task of selecting an appropriate molecule for development, then guiding it through many complicated and lengthy studies before submission to the FDA, first as an Investigational New Drug application (IND), then later as a New Drug Application (NDA).

R&D Services (RDS) Pharma Consulting offers consulting services in drug discovery, preclinical and early to mid stage clinical drug development to small and medium size companies who have limited capacity and expertise available to them in the areas of drug metabolism, ADME and pharmacokinetics. In the Drug Discovery phase, RDS provides the expertise to evaluate screening data and help select molecules with acceptable pharmacokinetic and other ADME properties. Continuing through the lead optimization to the preclinical and early clinical development phases, RDS provides laboratory qualification, study design, placement and monitoring, project management, DM and PK data analysis, first in human dose calculations, and finally, report and submissions writing services to help clients file their IND, then progress into their Phase I and II clinical trials.  Clinical experience includes single and multiple ascending dose, drug interaction, food effect and human mass balance studies.

The RDS consultants have an average of over 30 years experience in preclinical and clinical drug development and have been involved in IND and NDA applications of several molecules. This gives us insight into how to recognize and solve potential problem areas, how to conduct appropriate studies and how to prepare drug applications.

OUR STAFF

Dr. Thomas Thompson
Dr. Greg Kochak
Dr. Don Reynolds