At PharmStat we help you turn DATA into KNOWLEDGE

We specialize in Statistics for Pharmaceutical Manufacture and Compliance in FDA regulated industry.

Carrying on a 30+ year tradition of cCGMP statistics and their pragmatic application, we are dedicated to “Validation By Design™" for the following goals:

  • Leading the application of Mathematics to solve problems of Industry and Government
  • Guiding clients through regulatory impacted statistical challenges and system design appropriate to their business needs
  • Teaching our passion for statistics and engineering

We have worked with large companies and small, saving millions of dollars, defending corporations, and facilitating transformation. Do you need to develop this expertise or just need an expert? Contact us for a free initial consultation on any statistical, manufacturing, or compliance issue.

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News & Events

Upcoming Course:
Tuesday, April 8, 2014

Statistical Process Control (SPC) Data: How It Is Used in Process Validation and Manufacturing, San Antonio, TX
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Upcoming Course:
May 5-6, 2014

“Introductory Design-of-Experiments“, University of Wisconsin-Madison Pharmaceutical Engineering Series Short Course, Madison, WI
Learn More and Register

Upcoming Course:
July 14-15, 2014

“Pharmaceutical Statistics: DoE Basics for Validation by Design“, 2014 DoE Week for Process Design and Process Optimization, Bethesda, MD
Learn More and Register

Upcoming Talk:
August 7-9, 2014

Land of Lakes Conference on Innovations in Pharmaceutical Analysis & Quality. Analytical Method Variability: Determination, Prioritization and Reduction, Madison, WI
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Upcoming Webinar:
Process Monitoring & Metrics to comply with FDASIA 705/706
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Upcoming Conference:
November 4-5, 2014

Parenterals 2014, Munich – Statistical methods to improve your manufacturing. 30 min presentation.

Upcoming Class:
November 4-5 & 6-7

Parenterals 2014, Munich – A two day training course, using TR 59 as a basis.

Recent Event:
December 9-10, 2013
PDA/FDA Pharmaceutical Quality Metrics Conference

Conference Mr. Jason Orloff presented on two panels at the 2013 PDA/FDA Pharmaceutical Quality Metrics Conference held December 9-10 at Bethesda, MD. The panels included 'Culture and Comparing Metrics' and the Closing Plenary Session. In his talks, Mr. Orloff discussed non-conformances in the global pharmaceutical market as related to the skyrocketing costs of healthcare as well as drug shortages. He explored how we came to this state by controlling variability by compliance with specifications, the challenges of specifications not set relevant to therapeutic and toxicological effect, and the new opportunities that a shift to performance against specifications could mean in light of FDASIA 705/706.