Pharmaceuticals

It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in compliance with the Food, Drug, and Cosmetic (FD&C) Act? A hearing was held on May 31 to discuss just that. Many...

India’s medical device market is growing exponentially. The medical device industry in India is presently valued at $5.2 Billion and is growing at 15.8% CAGR. Currently, India is considered among the top 20 global medical device markets and is the...

With the continued advances of Artificial Intelligence and Machine Learning (AI/ML), we are at the forefront of a new medical device era. In our previous blogs AN UPDATE ON FDA’S DIGITAL SOFTWARE PRE-CERTIFICATION PROGRAM and MODIFICATION AFTER INITIAL REVIEW AND...

Are you working with a product whose fitness for use or quality deteriorates over time? Does your Quality Management System support identification and controls of products storage and distribution requirements between following manufacturing and until placed in-service? The Quality Management System...

FDA defines data integrity as the completeness, consistency, and accuracy of data. Data Integrity is not a new concept and it has been a matter of concern since the paper and ink era. With the new computerized systems and cloud...

Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – reactive and proactive. Reactive is the most common approach used when setting up a PMS system, but that doesn’t mean a proactive approach isn’t...

Happy World Immunization Week! Lately, we’ve heard about outbreaks of diseases that we previously thought were preventable. What are some of the latest numbers and what can we do? This week’s blog is a snapshot of the impact of vaccines...

Happy New Year from EMMA International!   Your ‘one stop shop’ for all your quality, regulatory, and compliance needs.   The new year brings with it the halo of fresh starts and new opportunities.  What hasn’t changed are the usual constraints of time, budgets,...