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.

Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence

Access to trustworthy pharmaceutical information is essential for patient safety and informed decision-making. In the Netherlands, medical information (MI) services are central to this goal, providing healthcare professionals, patients, and caregivers with accurate, non-promotional product...

Meet the Expert Kamila Rocha

Meet the Expert: Kamila Rocha

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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Clinical Pharmacology Considerations for Peptide Drug Products, September 2023

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall...

Meet the Expert: Shauna Burns

Meet the Expert: Shauna Burns

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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Frequently Asked Questions About Clinical Trials Registration and Disclosure

In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever. Pharmaceutical and...

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Regulatory Sciences

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...

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EMA Policy 0070: Back on the Road to Transparency

By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy...

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Top 10 Best Practices for Successfully Obtaining Second Round of Funding for Biotech Startups

Securing funding is a crucial milestone for biotech startups aiming to advance their research and bring innovative products to market. Once the initial round of funding is secured, the next challenge...

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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;...

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Biotech Start Up: How to Transition from Early Phase Biotech to Late-Stage Biotech

Biotech startups face a number of challenges as they progress through the various stages of drug development. While early-stage biotechs focus on developing and testing their products, late-stage...

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COVID-19 and mRNA: A Vaccine Breakthrough

COVID-19 has presented humankind with the challenges expected from a pandemic with over 700 million cases and almost 7 million deaths1. While the mRNA technology was not widely known in the news, it...

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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...

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Clinical Research Solutions

What is the Drug Supply Chain Security Act (DSCSA)?

Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain....

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Clinical Research Solutions

Biotech Startup Approaching IND: 5 Mistakes to Avoid While Writing a Development Plan

In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and...

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Compliance Auditing: A Peek into Common Critical Findings

Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices. Compliance...

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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,...

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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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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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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Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

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The Impact of a US Government Shutdown on the Food and Drug Administration

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

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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...