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Life Science Consulting


Your source for content carefully curated for life science consulting, medical information, pharmacovigilance, and regulatory affairs professionals. ProPharma Group’s subject matter experts regularly share their expertise in the form of blogs, feedback regarding recent guidance and regulations, case studies, industry trends, and more.

Embracing Risk Management Principles: As Easy as One, Two, Three
Embracing Risk Management Principles: As Easy as One, Two, Three
March 12, 2020

In the pharmaceutical industry today, there are strict guidelines to adhere to…

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Event Recap: MHRA Good Practice Symposia Week
Event Recap: MHRA Good Practice Symposia Week
March 6, 2020

This year, four members of our team attended the MHRA Good Practice…

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Meet the Expert: Ewelina Czerniec-Michalik
Meet the Expert: Ewelina Czerniec-Michalik
March 4, 2020

ProPharma Group has launched a “Meet the Expert” series introducing you to…

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FDA: CGMP Consultant Recommendation
FDA: CGMP Consultant Recommendation
February 18, 2020

Reflecting on my interactions with FDA I have come to understand that…

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Establishing Process Equivalency
Establishing Process Equivalency
January 28, 2020

A common question when transferring an established process from one facility to…

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Phase Appropriate Controls and GMPs in Cell and Gene Therapy
Phase Appropriate Controls and GMPs in Cell and Gene Therapy
January 15, 2020

How much is not enough, and how much is too much when…

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How to Safely Launch Medical Cannabis Products in Germany
How to Safely Launch Medical Cannabis Products in Germany
January 2, 2020

Over the past few weeks the withdrawal of cannabis products from the…

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Five Steps Toward a Mature Data Integrity Culture
Five Steps Toward a Mature Data Integrity Culture
December 11, 2019

The corporate and quality culture has a significant effect on the maturity…

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Analytical Methods for the Investigation of Carcinogenic Nitrosamines in APIs and Drug Products
Analytical Methods for the Investigation of Carcinogenic Nitrosamines in APIs...
November 25, 2019

Since September 26, 2019, all EU Marketing Authorization Holders (MAHs) of medicines…

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Three Steps Towards Fulfilling the EMA Nitrosamine Advice
Three Steps Towards Fulfilling the EMA Nitrosamine Advice
November 11, 2019

Since September 26, 2019, all EU Marketing Authorization Holders (MAH) of medicines…

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Meet the Expert: Xenia Freifrau von Maltzan
Meet the Expert: Xenia Freifrau von Maltzan
October 16, 2019

ProPharma Group has launched a “Meet the Expert” series to introduce you…

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Understanding the EMA Advice on Nitrosamine Presence
Understanding the EMA Advice on Nitrosamine Presence
October 16, 2019

On September 26, 2019, the European Medicines Agency (EMA) released an advice…

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Just How Mature Is Your Data Lifecycle / Data Management Function?
Just How Mature Is Your Data Lifecycle / Data Management...
October 15, 2019

The attention of regulatory agencies continues to focus on data integrity, as…

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Meet the Experts: Marc Stegeman and Jan Zorgdrager
Meet the Experts: Marc Stegeman and Jan Zorgdrager
October 14, 2019

Learn how Marc and Jan are working to globally support ProPharma Group's…

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Meet the Expert: Robert Kuntz
Meet the Expert: Robert Kuntz
September 23, 2019

ProPharma Group has launched a “Meet the Expert” series to introduce you…

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Get the Most Out of Your GMP Effectiveness Checks
Get the Most Out of Your GMP Effectiveness Checks
July 29, 2019

We work in a highly regulated industry.  Whether you are associated with…

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Deviations: Beyond the Basics
Deviations: Beyond the Basics
June 25, 2019

There are plenty of guidelines and instructions on implementing a deviation system…

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Meet the Expert: Abel C. Cortez
Meet the Expert: Abel C. Cortez
June 19, 2019

ProPharma Group has launched a “Meet the Expert” series to introduce you…

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FDA’s Top 483 Observations for 2018: A Reflection of Industry’s Compliance
FDA’s Top 483 Observations for 2018: A Reflection of Industry’s...
May 30, 2019

At the beginning of each federal fiscal year, the US FDA posts…

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Meet the Expert: Marc Klinkhamer
Meet the Expert: Marc Klinkhamer
May 9, 2019

ProPharma Group has launched a “Meet the Expert” series to introduce you…

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