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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.

Life Science Consulting

December 6, 2022

Changes to the Animal Welfare Act Affecting Animal Research Facilities

Does your organization conduct or outsource testing to an Animal Research Facility?  If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...

Life Science Consulting

November 1, 2022

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...

Life Science Consulting

October 28, 2022

ProPharma Group's Dr David Crome to Act as Compliance Monitor to the MHRA

From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have...

Life Science Consulting

October 26, 2022

Your Vendor Audit Program: On-site or Remote / Virtual?

It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...

Life Science Consulting

October 20, 2022

Clinical (IMP) Drug Supply…It’s Complicated

Things to consider and how to ease the process IMP Supply Management is a journey where GMP meets GCP and GDP. This journey includes finance, flow of products and documentation. How a company manages...

North America FDA News

August 30, 2022

USP and FDA Propose Updates to Good Storage and Distribution Practices

Updates have been announced by FDA and for USP <1079>. In this blog we cover these changes. USP USP <1079> has a series of chapters on Good Storage and Distribution Practices. Chapter <1079> applies...

Medical Device PDP

August 15, 2022

FDA Pathways to Medical Device Approval

FDA Pathways to Medical Device Approval: Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical...

PDP PMA

August 9, 2022

From Idea to Market: The Five Stages of Product Development

From Idea to Market: The Five Stages of Product Development. The exact product development process for medical devices differs from region to region, with different regulatory expectations that need...

Meet the Expert Renata Pankiewicz

August 8, 2022

Meet the Expert: Renata Pankiewicz

Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...

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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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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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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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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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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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.