Full Development Support

We provide the following services in the full-development setting:

What we do

Full development services

We provide the following in the full-development setting:

Design of your pivotal study including all Clin Pharm components and sampling schedule

Analysis of Clin Pharm data from the pivotal study, including full pharmacometrics analysis

NDA and BLA support

Submission-ready pharmacometrics reports: population-PK, exposure-efficacy, exposure-safety, concentration-QT

Summary of Biopharmaceutic Studies (SBS) and Module 2.7.1; Summary of Clinical Pharmacology Studies (SCP) and Module 2.7.2

Coordination of messaging between SBS, SCP, CO, SCE and SCS

Clin Pharm sections of USPI and SmPC

Pre-NDA/BLA Briefing Document and company position; attendance at pre-NDA/BLA meeting

Participation in Rapid Response Team (RRT) for FDA Information Requests

Asia/Pacific registration strategy including Japan (PMDA) and China (CDE)