thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

Compliance Supplier Management

July 10, 2018

Implementing a Risk-Based Supplier Management Program

According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...

FDA CAPA

January 11, 2017

CAPA is not a difficult concept, so why do many companies have difficulty managing it?

CAPA is not a difficult concept, so why do many companies have difficulty managing it?: If keeping up with CAPA is a challenge for your company's cGMP quality system, I hope that this article...

Quality Assurance Life Science Consulting

September 7, 2016

Does Your Training Program Have Traction?

With the spotlight these days on Data Integrity, it may be easy to lose sight of some fundamental Quality Systems. Core Quality Systems include Document Management, Investigation Management, and...

Quality Assurance Life Science Consulting

May 11, 2016

Does your Quality System stand up to the challenge?

Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...

Quality Assurance Life Science Consulting

March 9, 2016

Gravity and Quality Assurance

As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations,...

Quality Assurance Life Science Consulting

March 25, 2015

CAPA and the Importance of Effective Technical Writing

My apologies to you in the technical writing profession out there, but there are not too many topics that are as bland and unappealing as technical writing. Personally, I'd rather step on a sharp...

Quality Assurance Life Science Consulting

September 10, 2014

Sneak Preview: What Will the Quality Metrics Initiative Look Like?

I had lunch in a restaurant the other day. During my meal, I noticed that there weren't many other customers. I didn't give it much thought until I walked out and read the restaurant's hygiene grade...

Quality Assurance Life Science Consulting

June 27, 2014

Who Owns Quality?

When it comes to the Healthcare industry (e.g. pharmaceuticals, medical devices, dietary supplements, etc.) who owns a company’s Quality Assurance practices? Without a doubt the Quality organization...

Quality Assurance Life Science Consulting

November 26, 2013

Why Measure and Report Quality Metrics?

A wise man recently told me that “honor and respect should be given freely, but trust is earned”. Whether it’s in politics, friendships, church, marriages, parenting or even the business world,...

Statistical Intervals Confidence Interval Process Validation Life Science Consulting featured-image

Aug 15, 2013 12:00:00 AM

Understanding Statistical Intervals: Part 2 - Prediction Intervals

Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...

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General Regulatory Drug Approval Regulatory Sciences featured-image

Mar 29, 2022 12:00:00 AM

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

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Biostatistics Clinical Research Solutions featured-image

Dec 22, 2020 12:00:00 AM

How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...

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ICH MW QC CSR Clinical Research Solutions featured-image

Dec 8, 2020 12:00:00 AM

A Guide to the Clinical Study Report

What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...

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General Regulatory FDA Meetings Regulatory Sciences featured-image

Feb 28, 2017 12:00:00 AM

Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products

On March 10, 2015, the FDA published a draft guidance, providing a number of recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are intended to...

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Regulatory Sciences featured-image

Oct 12, 2022 12:00:00 AM

Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA

For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...

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Inspiring the Future of Drug Development

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