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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.

Technology Transfer Analytical Method Transfer Checklist

January 13, 2021

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...

Technology Transfer Life Science Consulting

September 14, 2016

How critical is the Technology Transfer phase of new drug development?

During the development phase of a new drug, great pains are taken to characterize the molecule and to run a myriad of laboratory and animal tests to determine the product attributes, toxicology...

Technology Transfer Life Science Consulting

July 2, 2014

GAMP® 5 Concept 2 – System Life Cycle

So far in our series on GAMP 5 we’ve provided a high level overview of the five major GAMP concepts, and a more in depth discussion of Concept 1, Process Knowledge and Understanding. In this...

Technology Transfer Life Science Consulting

May 28, 2014

GAMP® 5 Concept – Process Understanding

In my previous blog I re-visited key GAMP® 5 concepts as they relate to establishing a compliant system validation methodology. My next few blogs will focus on each of these concepts in more detail....

Technology Transfer Life Science Consulting

May 7, 2014

Post-Validation: Gate Nine of the Nine Gate Transfer Process

As the pharmaceutical supply chain evolves, at some point product/technology transfers will become part of the improvement process. When transferring production from site to site, an array of complex...

Technology Transfer Life Science Consulting

April 9, 2014

GAMP® 5 Basis for Quality System Compliance

Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle...

Technology Transfer Life Science Consulting

April 2, 2014

Process Validation: Gate Eight of the Nine Gate Transfer Process

  Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: AssessmentGate 2:...

Technology Transfer Life Science Consulting

March 5, 2014

Ready for cGMP Validation: Gate Seven of the Nine Gate Transfer Process

Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...

Technology Transfer Life Science Consulting

February 12, 2014

Formulation and Process Development: Gate 6 of the Nine Gate Transfer Process for Moving Production

Today, we are continuing our blog series on the Nine Gate Transfer Process for Moving Production from Site to Site, with  Gate 6: Formulation and Process Development. If you have missed any previous...

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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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...

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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...

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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...

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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...

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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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