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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.

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 Agency Alerts

February 28, 2017

How Important are Clinical Trials in Today’s World of Regulation?

Eliminating clinical trials would be extremely detrimental to the safety and well-being of people all over the world. On Friday, February 24th, The Washington Post published an article written by...

Quality & Compliance GCP

October 26, 2016

#10: Investigator Responsibilities – Protecting the Rights, Safety, & Welfare of Study Subjects

In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations.The guidance, entitled Investigator...

Quality & Compliance Agency Alerts

September 21, 2016

Multi-Regional Clinical Trials 102: Clinical Trial Design & Protocol-Related Issues

Additional information on the guidance document is available in our preceding FDA News article entitled "Multi-Regional Clinical Trials 101: Value, Requirements, and Key Considerations Associated...

Quality & Compliance Agency Alerts

September 20, 2016

Multi-Regional Clinical Trials 101: Value, Requirements, and Key Considerations Associated with MRCTs

On Friday, September 9th, the FDA announced the availability of a draft guidance entitled “E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.” The draft guidance, which...

Quality & Compliance GMP

August 24, 2016

FDA Embarks on Warning Letter “Rampage”

Last week the FDA released an astonishing 23 warning letters along with an import alert to a number of companies located across the globe. According to a recent article from Law360, the letters were...

Quality & Compliance Agency Alerts

July 29, 2016

EMA Recommends Suspension of Numerous Drugs Due to Faulty Testing

On Friday, July 22nd, the European Medicines Agency (EMA) recommended the suspension of hundreds of drugs that had undergone bioequivalence testing at Semler Research Centre Private Ltd., a clinical...

Quality & Compliance GMP

July 12, 2016

FDA Addresses Extrapolating Adult Data for Pediatric Use

In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...

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