Pharmacovigilance has always been a crucial component of the biopharmaceutical industry, but it has become even more so over the last decade. During that time, regulatory authorities developed enhanced safety documentation protocols and increased warnings and awareness about drug-specific…

COVID-19 Summer Resurgence: What Biotechnology Companies Can Do To Prepare for the Next Pandemic Before COVID-19, many Americans associated the word ‘pandemic’ with movies and TV shows; the topic made for a good story but had no basis in…

Women account for nearly half the human population (49.6%), but are often excluded from clinical trials and medical research. Unfortunately, this lack of inclusion has real-world consequences.  A recent study published in the Annals of Internal Medicine found that…

Preparing for ICH GCP E6 R3 The International Council for Harmonization’s (ICH) guidelines received a major update in 2023 with the introduction of ICH E6(R3). This new protocol provides an outline for ensuring patient safety and data quality during…

Launching a New Product: Important Considerations for Chief Medical Officers (CMOs) As Chief Medical Officer (CMO), it is your job to ensure patient safety throughout the drug development process. You also play an essential role in the activities leading…

There’s never been a more exciting time for medical innovation. Since 2015, the industry has exploded, seeing an average of 150 new biotech startups launch each year. This growth is encouraging and promises a bright future –– especially for…

In the world of biotech, regulatory inspections are an ever-looming concern. Health authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others routinely conduct inspections to ensure compliance with applicable regulations and…

 Trial Master Files (TMF) provide a place to collect data and store regulatory information surrounding the development of new drugs and devices and are an essential component to all clinical studies. Moreover, the TMF documents your quality control procedures…

It’s hard to believe, but 2023 is soon coming to a close. With the new year right around the corner, now is the perfect time to start thinking about and planning for your GxP vendor audits. Dealing with audits…

A fully functioning pharmacovigilance program is essential in any clinical study for a drug, biologic or medical device. If you don’t take the time to monitor, assess, and manage adverse reactions, you risk potentially devastating economic consequences or worse; endangering…