Regulatory Interactions and Submissions  ​ 

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

TM

Start up

Translational Medicine

Early signal detection for efficacy, safety and biomarkers

Modeling & Simulation

Due Diligence

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.

Start Up and Biotech R&D Consultancy​ 

Enable start ups to have access to a full range of clinical pharmacology and early development expertise 

Translational Medicine

SMS

Strategic Modeling & Simulation

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.

KEY EXPERTISE 

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.  

CLINICAL PHARMACOLOGY

DRUG DEVELOPMENT & PROGRAM TECHNICAL OVERSIGHT

DD

ICP

Integrated Clinical Pharmacology

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.

Regulatory