thought leadership

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.

Compliance

March 15, 2019

Assumed Brexit & Batch Control Testing Site In the UK

The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...

Compliance Life Science Consulting

March 6, 2019

Health Apps and the Requirements Imposed By the Law

If you check Apple’s App Store or Google’s Play Store you will find an overwhelming list of health and fitness apps. This list only gets longer, if you include the number of people who use these...

Compliance Life Science Consulting

February 21, 2019

7 Things to Consider in Medicinal Cannabis Development

Mention the word cannabis and the confusion starts; legal or illegal, nutraceutical or medicinal product, psychoactive or non-psychoactive, clinically significant or not. At the same time, the...

Compliance Life Science Consulting

November 29, 2018

Industry Poll: How Can Your GMP Auditing Program Be Most Improved

Recently, ProPharma Group conducted a poll to quality professionals across the country to understand the challenges that FDA regulated companies face in managing their GMP auditing programs. As...

Compliance

October 16, 2018

Outdated Facilities – Bring Back the ‘c’ in cGMP

New rules, old facilities. How do these two meet? Is it a big black hole or is there light at the end of the tunnel? When you work in an older facility, you are probably acquainted with one-liners...

Compliance

September 5, 2018

Industry Poll: What are the Leading Challenges with GMP Auditing?

In a recent poll conducted by ProPharma Group, the question “What is your biggest GMP auditing challenge?” was posed to Quality professionals in the drug manufacturing industry. The following graph...

Compliance Supplier Management

July 10, 2018

Implementing a Risk-Based Supplier Management Program

According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...

Compliance Life Science Consulting

January 10, 2018

FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance

At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...

Compliance FDA

July 6, 2017

How to Write an Effective Quality Investigation Report

In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...

Prev 1 2 3 4 5

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.