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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.

FDA CGT

July 13, 2022

7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing

Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CGT) products is extremely complex. The choice of a reliable Contract...

Quality & Compliance GMP

June 6, 2019

Why the FDA Should Never Be Your First Inspection

You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...

Quality & Compliance GMP

December 4, 2018

Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations

Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...

Quality & Compliance GMP

July 23, 2018

FDA Announces Voluntary Recall of Drugs Containing Valsartan

On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...

Quality & Compliance GMP

November 6, 2017

FDA Takes Steps to Improve Efficiency of Global Pharmaceutical Manufacturing Inspections

On Tuesday, October 31st, the FDA announced that it will begin allowing eight European drug regulatory authorities to conduct inspections of manufacturing facilities and determine whether or not they...

Quality & Compliance GMP

June 28, 2017

Sterility Concerns Cause Voluntary Recall of Various Products: Potassium Phosphate & Succinylchoine Chloride

On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the...

Quality & Compliance GMP

May 31, 2017

FDA Warns Drug Manufacturers of Recalls due to BCC Contamination

On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC).  According to FDA’s warning, “BCC and other...

Quality & Compliance GMP

May 2, 2017

Clinical Quality Systems & the Outsourced Model

The landscape of clinical trials is evolving.  The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols.  As...

Quality & Compliance GMP

February 15, 2017

Indian API Manufacturer Fails to Correct Significant GMP Deviations, Receives FDA Warning Letter

In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility.  During this inspection, the FDA investigator observed a number of significant deviations from...

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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