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.

Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance

The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion

The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food and Drug Administration (FDA), is responsible for ensuring prescription drug advertising and...

Quality & Compliance

EU Pharmaceutical Legislation Revisions FAQ

On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following...

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Clinical Research Solutions

The Care and Feeding of FDA PMAs: Mastering Premarket Approval

Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...

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Quality & Compliance

Navigating EU GMP Compliance: A Consultant's Guide to Smooth Sailing

Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...

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Quality & Compliance

Navigating the Regulatory Maze: Clinical Data for Medical Device Approval

In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...

Quality & Compliance

Building Clinical Quality Assurance: Unlock the Full Potential of Your Clinical Development

In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic. With...

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Quality & Compliance

Staying GMP Compliant: A Consultant's Guide to Compliance Bliss

Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...

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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...

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