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

Full Development Support

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

Analysis of Clin Pharm data collected in the pivotal study including all pharmacometrics analysis
NDA and BLA support

Preparation of submission-ready pharmacometrics reports including population-PK report, exposure-efficacy report, exposure-safety report and concentration-QT report

Preparation of submission-ready documents 

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 and CO, SCE and SCS

Preparation of Clin Pharm sections of USPI and SmPC

Preparation of pre-NDA/BLA Briefing Document and company position

Attendance in pre-NDA/BLA meeting to defend the company position

Participation in the Rapid Response Team (RRT) to address any potential FDA Information Requests

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

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