Welcome to PharmaPRO Consulting

We partner with pharmaceutical and biotechnology to rapidly advance new agents from IND to NDA.

As Medicine has advanced, so have the demands placed on pharmaceutical and biotechnology companies to bring their novel drugs and products to market in a cost- and time-efficient manner. The key to their success remains unchanged, well-designed and executed clinical trials, robust statistical analyses, flawless data collection, and intelligently conducted data analyses. In today’s environment, many companies, large and small, have found success in teaming with specialized consultancy partners to accomplish the myriad of tasks necessary for each regulatory submission.

PharmaPRO Consulting offers consultancy services to the pharmaceutical and biotechnology industries. Our expertise is in the areas of:

  • Regulatory Strategy
  • Regulatory Submissions
  • Clinical Pharmacology 
  • Preclinical, ADME, and DMPK
  • Pharmacokinetic data analysis
  • Toxicology/toxicokinetic data analysis
  • Drug metabolism and Drug-drug interaction studies, Special Patient Population Analyses
  • Pharmacokinetics and Pharmacodynamics Modeling and Simulation
  • Population PK Analysis
  • Data management

We have expertise to support:

  • Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
  • Breakthrough Therapy Designation Development, Review, and Approval
  • Biosimilar Development, Review, and Approval
  • Generic Drug Development, Review and Approval

Contact us to learn more about how partnering with PharmaPro Consulting can help you meet your goals across the full spectrum of drug development.

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