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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.

Compliance

April 7, 2020

Top Tips for a Successful Virtual Audit

The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...

Compliance Life Science Consulting

March 12, 2020

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

In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than...

Compliance Life Science Consulting

March 7, 2020

Event Recap: MHRA Good Practice Symposia Week

This year, four members of our team attended the MHRA Good Practice symposium week. Part of this week were the GPvP Symposium and the joint MHRA and FDA GCP Symposium. Part of ProPharma Group’s...

Compliance

February 18, 2020

FDA: CGMP Consultant Recommendation

Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...

Compliance Life Science Consulting

July 29, 2019

Get the Most Out of Your GMP Effectiveness Checks

Get the Most Out of Your GMP Effectiveness Checks: We work in a highly regulated industry.  Whether you are associated with the manufacturing of a drug, a biologic, or a device, you understand the...

Compliance Uncategorized

June 25, 2019

Deviations: Beyond the Basics

Deviations: Beyond the Basics: There are plenty of guidelines and instructions on implementing a deviation system in a pharmaceutical/medical device company. However, there is a big difference...

Compliance Life Science Consulting

May 30, 2019

FDA’s Top 483 Observations for 2018: 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. Inspections ending between 10/1/2017 and 9/30/2018, for...

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...

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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

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