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.

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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Utilizing an Agile Framework When Implementing ATMPs
Utilizing an Agile Framework When Implementing ATMPs
April 11, 2019

Who says you can’t teach an old dog a new trick? Having…

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Health Apps and the Requirements Imposed By the Law
Health Apps and the Requirements Imposed By the Law
March 6, 2019

If you check Apple’s App Store or Google’s Play Store you will…

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7 Things to Consider in Medicinal Cannabis Development
7 Things to Consider in Medicinal Cannabis Development
February 21, 2019

Mention the word cannabis and the confusion starts; legal or illegal, nutraceutical…

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Innocent Until Proven Guilty: Hypothesis Test
Innocent Until Proven Guilty: Hypothesis Test
January 8, 2019

Each of us makes important decisions that shape our lives, every day. …

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Industry Poll: How Can Your GMP Auditing Program Be Most Improved
Industry Poll: How Can Your GMP Auditing Program Be Most...
November 29, 2018

Recently, ProPharma Group conducted a poll to quality professionals across the country…

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The Important Role of Advanced Therapy Medicinal Products
The Important Role of Advanced Therapy Medicinal Products
November 15, 2018

Increasing safe and effective patient treatment opportunities for the future is one…

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Data Integrity: 5 Ways to be GxP Compliant
Data Integrity: 5 Ways to be GxP Compliant
September 14, 2018

Are you always ready to be inspected for your (GxP) activities in…

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Implementing a Risk-Based Supplier Management Program
Implementing a Risk-Based Supplier Management Program
July 10, 2018

According to recent FDA updates on the implementation of the Safety and…

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