<iframe src="https://www.googletagmanager.com/ns.html?id=GTM-WR9VRVQ" height="0" width="0" style="display:none;visibility:hidden">
Back to News & Insights

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.

Inspiring the Future of Science to Deliver a Better Tomorrow

April 7, 2023

ProPharma’s Research Consulting Organization (RCO) model offers a fully customizable alternative for partnership with clients and sponsors. This year’s theme for World Health Day Health For All...

Read The Post
Quality & Compliance EudraLex Volume 4

April 24, 2023

Revised Annex 1, EudraLex Volume 4: Deadline to Comply: August 2023

August 25th, 2023 is the deadline to comply with the revised EudraLex Volume 4, Annex 1. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...

Read the Article
Life Science Consulting EudraLex Volume 4

October 8, 2020

EudraLex Volume 4, Annex 1 Update: What You Need to Know

EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision...

Read the Article
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...

Read More
General Regulatory Drug Approval Regulatory Sciences featured-image

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...

Read More
Biostatistics Clinical Research Solutions featured-image

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...

Read More
ICH MW QC CSR Clinical Research Solutions featured-image

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...

Read More
General Regulatory FDA Meetings Regulatory Sciences featured-image

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...

Read More
Technology Transfer Analytical Method Transfer Checklist USP Tech Transfer Life Science Consulting featured-image

Jan 13, 2021 12:00:00 AM

Analytical Method Transfer Checklist

As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist...

Read More

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.

Speak with an Expert