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PMA Post-Approval Study Considerations

In the US, post-market clinical studies are not required of every medical device manufacturer. However, the Food and Drug Administration (FDA) does have the authority to order post-market surveillance of any device, and for devices in the Premarket Approval (PMA) pathway, this may come in the form...

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Clinical Research Solutions

What is a Clinical Evaluation Report (CER)?

If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term ‘CER’ or Clinical...

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Clinical Research Solutions

Navigating Uncertainty with the FDA LDT Rule

On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for...

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Medical Information

Enhancing Animal Health Compliance with Comprehensive Medical Information (MI) and Pharmacovigilance (PV) Services

Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and...

Quality & Compliance

Diary of Compliance: A Year in the Life of Ensuring FDA CAPA Standards

Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes...

Elderly Woman Checking Medical Information

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...

Person in lab coat investigating a medical device

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...

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...

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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...

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Medical Information

What are Patient Support Programs?

Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...

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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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...

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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