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.

Vigilance by Another Name

Do regulations and guidance documents sometimes stagnate your learning progress because of the terminology used? Regulation confusion is a common complaint heard from current and prospective new clients. To understand which rules apply in each situation, and to which parties, we have to first start...

Medical Information

Leveraging Offshore Excellence: Enhancing Medical Information Services Through Contact Centers in India & the Philippines

As the pharmaceutical landscape in the Japan and Asia-Pacific (JAPAC) region continues to evolve, the demand for efficient, high-quality medical information (MI) services has never been greater. Our...

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Quality & Compliance

What is GxP Compliance: A Detective’s Guide to Quality and Regulatory Compliance

Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked...

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...

Gloved worker working with medical devices

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...

Lab technician wearing hairnet mask and scrubs looking into microscope

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...

Regulatory Sciences

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

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Clinical Research Solutions

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...

Clinical Research Solutions

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...

Casually dressed business professionals discussing intensely at a conference table

Regulatory Sciences

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

Healthcare worker showing a woman details on a tablet device.

Medical Information

What are Patient Support Programs?

Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...

Clinical Research Solutions

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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