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.

Advances in AI for Digital Transformation: Insights from BioIT World 2025

While AI has been topping the agenda at most industry events for several years now, the progression from futuristic vision to nearly commodity capability was particularly apparent at BioIT World 2025. With four conference tracks focused on different types of AI and specialist exhibitors such as...

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Quality & Compliance

Ensuring Quality in Clinical-Phase Drug Manufacturing: A Comprehensive Guide

Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...

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Regulatory Sciences

How a Strong Regulatory Strategy Supports Your Product’s Success

One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...

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Medical Information

Risks to Consider when Implementing AI Technology in Medical Information

AI is a highly praised tool to implement across industries and service lines and Medical Information (MI) is no exception. In Medical Information, AI is embedded in a workflow for patients and...

Regulatory Sciences

FDA Drug Labeling Requirements & Regulations: What’s in Your Label?

Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters? A drug’s label...

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Pharmacovigilance

Common Challenges in Signal Detection in Pharmacovigilance and How to Overcome Them

In pharmacovigilance, recognizing and responding to safety signals quickly can be crucial for patient safety. A "signal" in pharmacovigilance refers to a hypothesis, supported by evidence, of a new...

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Quality & Compliance

15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?

Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific...

R&D Technology

Digital Transformation in Life Sciences: The Importance of Data Strategy

What is Digital Transformation? While there are many different definitions of digital transformation in life sciences, the core concepts they all have in common are digital technology and creating...

Regulatory Sciences

FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements

Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template. Sponsors need...

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Pharmacovigilance

Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

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