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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.

Cleaning Validation Life Science Consulting

August 17, 2016

cGMP for Phase 1 Investigational Drugs: Sterile Parenteral Drug Product Manufacturing

As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...

Cleaning Validation Life Science Consulting

January 28, 2015

Why Are My Swab Recoveries So Low?

Cleaning Validation and GMP reviews of those protocols are challenging. They become even more challenging at a Contract Manufacturing Organization (CMO) where compliance assessments to in-house...

Cleaning Validation Life Science Consulting

August 7, 2014

Are you moaning about cleaning?

From time to time in this industry, you will hear someone bemoaning the fact that they have to do a cleaning validation. If this happens to be you, have no fear and remember the following five points...

Cleaning Validation Life Science Consulting

June 11, 2014

The Cost of Inadequately Scheduling Cleaning Validation

Ever wonder why some—most—projects don’t go as planned? Let me take a chance at explaining what I have observed in the last few decades. Firstly, let us assume that you have contracted a well-known...

Cleaning Validation Life Science Consulting

March 27, 2014

Cleaning Disaster or True Worst Case?

How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time...

Cleaning Validation Life Science Consulting

August 8, 2013

Personalized Medicine – How Will the Batch Size Change Our Lives?

Hardly a week goes by without the announcement of a new scientific break-through in science and medicine that promises safer, more efficacious and personalized medicine.  Where are all these...

Cleaning Validation Life Science Consulting

June 13, 2013

Visual Inspection for Cleanliness, What Are We Missing?

As a way to verify that your cleaning or cleaning-in-place (CIP) process was successful, what tool, assay or method should you use first? Well, shouldn’t the answer be as plain as the eyes on your...

Cleaning Validation Life Science Consulting

May 21, 2013

Critical Process Parameters and Critical Quality Attributes: Why Does the Selection Process Take so Long?

Quick, can you name the top 10 Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) of your bio-pharmaceutical manufacturing process? Well if you hesitated don’t feel bad. Most...

Cleaning Validation Life Science Consulting

April 22, 2013

A Biotech Cleaning Validation Worst-Case Soil Selection

When conducting cleaning validation studies at large biologics or biotechnology facilities or perhaps even conducting a small cleaning validation study on a non-dedicated piece of equipment in the...

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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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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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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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

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.