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.

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XP Pharma Consulting’s Record of Success

  • Contributing to or reviewing more than 103 clinical studies in the following therapeutic areas:
    Analgesia, anesthesia, cardiovascular, central nervous system, hematology, infectious disease, metabolic and endocrine disorders, oncology, pediatrics, pulmonary, rare genetic diseases, and rheumatology
  • Completing more than 32 clinical pharmacology studies, including: Bioequivalence, drug-drug Interaction, food effect, multiple ascending doses, radio-labeled mass balance, single ascending dose, special population, and thorough QT studies
  • Contributing to the clinical development of more than 36 drugs, including: Small molecules, large molecules (monoclonal antibodies), RNA/RNAi therapeutics encapsulated with lipid nanoparticles, and enzyme replacement therapies
  • Contributing to the authorship of/reviewing more than 240 regulatory documents:
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12+

NDA/BLA (CTD 2.7.1 and 2.7.2 and sections of other CTD modules)

74+

PK, PK/PD Analysis, Reports

14+

Population PK Modelings

10+

Population PK/PD Modelings

68+

Clinical Study Protocols

62+

Clinical Study Reports

7+

Concentration-QT Analysis

2+

TQT Waivers

Are you interested in learning more?