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.
Analgesia, anesthesia, cardiovascular, central nervous system, hematology, infectious disease, metabolic and endocrine disorders, oncology, pediatrics, pulmonary, rare genetic diseases, and rheumatology
Bioequivalence, drug-drug Interaction, food effect, multiple ascending doses, radio-labeled mass balance, single ascending dose, special population, and thorough QT studies
Small molecules, large molecules, RNA/RNAi-based therapies, mRNA-based therapies, CRISPR-based genome editing therapies, and enzyme replacement therapies
NDA/BLA (CTD 2.7.1 and 2.7.2 and Sections of Other CTD Modules)
NCA PK, Exposure-Response Analysis, Reports
Population PK Modeling, Reports
Population PK/PD Modeling, Reports
Clinical Study Protocols
Clinical Study Reports
Clinical Pharmacology Strategy, Plans
TQT and DDI Study Waivers
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