The 21 CFR Part 4 final rule may seem like old news, but most of the combination products industry is still unclear what to focus on in order to be in compliance with the final ruling. Since the regulation went into effect in July, 2013, every combination products manufacturer is at risk to an audit. Here’s a quick guide to get you on the right path to full compliance before the auditors knock on your doors. Read more »

Ten years ago Quality Solutions Now (QSN) was founded with the vision of helping to create a world where companies protect and promote health by manufacturing safe and effective products that deliver cures, treatments, or preventions of diseases, or other medical conditions. Since that simple beginning in 2004, QSN has grown to now serve many medical device, drug and biologic manufacturing clients throughout the United States and internationally. Read more »