Prepare technical sections of IND, NDA and end of Phase I/II meetings with FDA and EMA. Member of sponsor team in FDA Advisory Board Meetings and EMA
Early signal detection for efficacy, safety and biomarkers
Program evaluation for mergers and acquisitions, benchmarking
Innovative Drug Development
Our experience in Modeling and Simulation is coupled with clinical pharmacology that provides a seamless solution for clients to save time or cost of development or guide the program at critical decision points.
Enable start ups to have access to a full range of clinical pharmacology and early development expertise
Pre-clinical and human PK and PK-PD, allometric scaling
We are a team of experienced drug development experts who utilize maximize gain from any data generated early in development programs and look for signs and markers that would guide decision making and program design.
Our extensive experience in clinical pharmacology and early development provide the expertise to design an efficient program and take development candidates from pre-IND through different phases in clinical development.
PK, PK-PD Studies, Phase I and Phase II
We design, oversee, analyse and interpret pre-clinical, as well as early and late phase clinical studies.
Studies include pharmacokinetics (PK), pharmacodynamics (PD), efficacy studies, drug-drug interactions, bioequivalance, first in human studies (single and multiple ascending dose), TQT, renal and hepatic impairment studies, age and gender studies. We also provide the same components where required in Phase 2 or Phase 3 studies.