Offering Professional Assistance for Your Drug Development Needs
At XP Pharma Consulting, we apply clinical pharmacology-guided and model-informed strategies to streamline every stage of drug development through registration. Our work combines advanced pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics to deepen understanding of drug behavior - empowering our clients to make faster, data-driven decisions and bring essential medicines to patients sooner.
ABOUT US
We act as an extension of your clinical pharmacology team combining scientific precision with strategic insight to accelerate every stage of your program. Whether you're preparing for your first-in-human study or optimizing your NDA submission, XP Pharma supports your program with the right pharmacology expertise at every milestone.
Clinical Pharmacology bridges the science of drug discovery with the realities of patient treatment. It explores how drugs interact with the human body - encompassing mechanism of action, formulation development, absorption, distribution, metabolism, and excretion (ADME), pharmacokinetics (PK), pharmacodynamics (PD), drug-drug interactions (DDI), safety, and efficacy.
The ultimate goal is simple yet critical: to ensure the right dose reaches the right patient at the right time. By integrating quantitative methodologies - including noncompartmental analysis (NCA), pharmacometrics, and model-informed strategies — within the framework of current regulatory expectations, Clinical Pharmacology enables more efficient, evidence-based drug development.
XP Pharma Consulting provides comprehensive Clinical Pharmacology services spanning:
Explore the sections below for detailed deliverables at each stage of development.
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
At XP Pharma Consulting, we combine deep expertise in clinical pharmacology, pharmacokinetics, and pharmacometrics to accelerate and strengthen your drug development program. Our consultants integrate seamlessly with your internal teams, applying rigorous quantitative approaches, validated computation methodologies, and regulatory insight to support every stage of development—from first-in-human studies through NDA and BLA submissions.
We go beyond delivering analyses to provide strategic interpretation—ensuring that every dataset informs sound clinical decisions and supports regulatory success. With a proven track record of high-quality deliverables and trusted partnerships across biotech and pharmaceutical organizations, XP Pharma Consulting is committed to helping you move forward with confidence.
Let’s collaborate to advance your therapeutic vision to patients faster—through clarity, precision, and scientific excellence.
View Case Studies
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
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