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.

Regulatory Sciences Market Access

September 7, 2023

Navigating Market Access & Reimbursement Strategy for Medical Products

Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors. One critical aspect that often...

Regulatory Sciences

August 30, 2023

A Closer Look at FDA's Nitrosamine Impurity Regulations for NDSRIs

FDA Provides Acceptable Intake Limits for Nitrosamines Drug-Substance Related Impurities (NDSRIs). Can You Comply? The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled;...

EU Regulatory Sciences

August 17, 2023

EU Pharmaceutical Legislation Reform

On April 26th, 2023, a Commission formed by the European Health Union proposed a groundbreaking revision of the EU’s Pharmaceutical legislation, marking the most significant reform in over two...

MHRA Regulatory Sciences

August 7, 2023

International Recognition Framework (IRF): Are You Ready?

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new international recognition framework (IRF) for medicines and devices. The IRF will be in place from January 1st,...

FDA Regulatory Sciences

August 4, 2023

FDA Proposes New, Easy-to-Read Medication Guide for Patients

The US Food and Drug Administration (FDA) has proposed a new, easy-to-read medication guide for patients known as the Patient Medication Information (PMI)1. The new medical guide will be required for...

EMA Regulatory Sciences

August 3, 2023

Integrity and Reliability Concerns in Bioequivalence Studies: An Insight into the Synapse Labs Inspection

In a globalized pharmaceutical industry, ensuring the integrity and reliability of clinical data is of utmost importance. Recently, the Spanish Medicines Agency conducted a comprehensive Good...

FDA Guidance Regulatory Sciences

July 26, 2023

FDA Issues Draft Guidance on Psychedelic Drug Development

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance on the development of psychedelic drugs. There has been a growing interest in using psychedelics for the treatment of...

FDA Regulatory Sciences

July 20, 2023

FDA's Concern over Diethylene Glycol (DEG) and Ethylene Glycol (EG) Contamination

Recent contamination of several drug products in India resulting in fatalities have prompted a new FDA guidance entitled "Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch...

Meet the Expert Regulatory Sciences

July 13, 2023

Meet the Expert: Jens van Wijngaarden

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...

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Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.