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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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