Whether you call it outsourcing, partnering or another term, hiring specialty expertise consultants continues to be a growing trend in the healthcare industry. Driven by the constant need to reduce operating costs to cope with budget cuts, downsizing and layoffs, drug, medical device, biologics, and combination products manufacturers are increasingly turning to outside consultants with specialty expertise and technical know-how of the constantly changing quality regulations to supplement their internal teams in a more cost effective manner. Read more »
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 »
Can you believe it is officially fall? They say time flies when you’re having fun and that has proven to be the case here at QSN. Last time we connected I mentioned we were almost at the finish line with the development of our new logo and we were getting ready to begin work on our new website. I am happy to report that we finally crossed one of these big items off our “to do” list! Here’s a quick update on that and some other exciting news at QSN. Read more »
