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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.

Quality & Compliance Biotech Startup

August 31, 2023

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...

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;...

Quality & Compliance Biotech Startup

August 24, 2023

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...


August 21, 2023

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...

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...

Medical Information Drug Supply Chain Security Act

August 15, 2023

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....

IND Clinical Research Solutions

August 14, 2023

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...

Compliance Quality & Compliance

August 10, 2023

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...

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,...

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Inspiring the Future of Drug Development

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