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IND Submission: The Key Step in the FDA Approval Process

Blog IND Submission and Its Role in the FDA Drug Approval Process Did you know that only one out of every ten drugs that go into clinical trials passes testing and gets approval from the government? This statistic is a clear reminder of how difficult it is to bring a new drug to market. It demonstrates how […]

How Can a Document Management System Help You Achieve FDA Compliance?

Blog The Connection Between Using a Document Management System and FDA Compliance Labs that receive FDA warning letters must waste valuable resources to become compliant again and resume work. The time, energy, and money used to compensate for FDA warning letters are better spent on continuing the lab’s research. One way to ensure you’re on […]

What Is FDAs DART Fit for Use Pilot All About?

Blog Expansion of FDA Data Standardization Rules with FDAs DART Fit For Use Pilot In drug development, the Food and Drug Administration (FDA) issued final guidance on reproductive and developmental toxicity. DART studies are critical for many potential new drugs. Standardizing this study data is a priority for the FDA. Standardization helps the agency process […]

The latest FDA Warning Letter and Inspection Observation Trends

Blog FDA Warning Letter and Inspection Observation Trends With the Food and Drug Administration (FDA) stepping up its enforcement efforts, companies are facing increased scrutiny in the form of more warning letters and inspections. However, staying informed and compliant with FDA regulations doesn’t have to be a daunting task. In this blog, we provide a […]