11 Coventry Ln,
Stoneham, MA 02180

About XP Pharma Consulting

About XP Pharma Consulting

XP Pharma Consulting, LLC. is committed to delivering independent and objective clinical pharmacology advice to the pharmaceutical industry. Every member of XP Pharma Consulting staff strives to provide our clients with superior advice, analysis, work product and program assistance.

Unparalleled Industry Experience

Our senior consultants all have 20+ years of industry experience and advanced degrees in their respective fields and can provide expert guidance in the areas of clinical pharmacology and pharmacokinetics (PK), pharmacometrics (PM) in your drug development program. We are experienced in supporting data analysis and document preparations including:

  • NDA/BLA (CTD m.2.7.1 and m.2.7.2 and other modules for biopharmaceutics, clinical pharmacology, and dose justification)
  • 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 study Waivers
  • DDI Study Waivers

Effective Organization

XP Pharma’s flexible structure allows us to customize our services to suit our clients’ needs. Our consultants can work as an extension of your team and/or to provide support for your complex projects that require broader experience and expertise:

  • Pharmacokinetics
  • Clinical Pharmacology
  • Clinical Studies
  • Regulatory Strategy for NDA/BLA
  • Pharmacometrics (PK/PD modeling and simulation)
  • Translational science (DMPK/Toxicology/Pharmacology)
  • Scientific Writers (regulatory documents).

A Step Above

The broad scope of XP Pharma’s experience combined with effective internal procedures put us a step above our competitors. We ensure:

  • Focused expertise in regulatory clinical pharmacology, translational science, small molecule and biologics development
  • Clients’ needs are matched to the most qualified consultant.
  • Detailed attention to each client and to every detail
  • Client projects are never left stagnant; timelines are established and met