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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.

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with the reality of limited resources. For many companies, regardless of size and tenure, the...

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Medical Information

A Journey Through ProPharma's REMS Program Support

This fictional story illustrates how ProPharma can seamlessly support a REMS program to ensure patient safety, access to medication, and regulatory compliance. Through scenarios involving healthcare...

R&D Technology

Evolving at the Speed of Science: How to Future-Proof your Benchling Platform

Science and technology are evolving rapidly, with an explosion in machine learning (ML) and artificial intelligence (AI) creating new possibilities for scientific discovery, operational efficiencies,...

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Quality & Compliance

Breaking the Chains of Project Management Dysfunction

Right now, you are sitting in front of your computer and wondering how, based on current project status, you will achieve your remaining project goals for the year or achieve those planned for the...

Medical Information

Patient Support Programs in India: Overcoming Barriers with Healthcare Access

Current Landscape of Medication and Healthcare Access in India India's healthcare system is a complex landscape with significant disparities in access to medical services and medications. Despite...

Medical Information

Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program

What is REMS? A Risk Evaluation and Mitigation Strategy (REMS) is a critical component of modern pharmaceutical regulation, designed to ensure that medications with serious safety risks are used...

Meet the Expert: Andrew Bright

Quality & Compliance

Meet the Expert: Andrew Bright

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Regulatory Sciences

Act Now! Navigating the Windsor Framework in the UK

A New Era for Pharmaceutical Development and Licensing in the UK The Windsor Framework, set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for...

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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...

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Quality & Compliance

GxP Readiness and Auditing: Your Quality System’s Insurance Policy for Compliance Systems

In the world of pharmaceuticals, biotech, and medical devices, maintaining compliance with Good Practices (GxP) is critical to ensuring product safety, efficacy, and quality. But how do companies...

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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...

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...

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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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...

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