Achieve Regulatory Approval With Our Help
The path to regulatory approval is full of pitfalls and sometimes, organizations need some help navigating the regulatory environment. Our experience can guide you through that sometimes-complicated process and help you to design a program to investigate and determine the pharmacokinetics (PK) and pharmacodynamics (PD) of your drug.
XP Pharma Consulting works with your team to aid informed decision-making and avoid regulatory rejection by facilitating a solid understanding of your drug’s PK and PD properties and PK exposure-response relationships.

XP Pharma Consulting’s Record of Success

12+
NDA/BLA (CTD 2.7.1 and 2.7.2 and Sections of Other CTD Modules)
80+
NCA PK, Exposure-Response Analysis, Reports
18+
Population PK Modeling, Reports
14+
Population PK/PD Modeling, Reports
73+
Clinical Study Protocols
66+
Clinical Study Reports
23+
Clinical Pharmacology Strategy, Plans
16+
TQT and DDI Study Waivers
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