Regulatory Guidance, Compliance Strategies, and Expert Insights for Regulated Industries
Navigating the complexities of FDA regulations, ISO standards, and evolving compliance frameworks requires more than just awareness — it demands expertise, insight, and reliable guidance. At Quality Solutions Now, our News and Advice hub delivers authoritative content designed to help medical device manufacturers, pharmaceutical firms, biotech companies, and combination product developers stay informed and proactive. From project management best practices to risk mitigation strategies, our articles and resources reflect the depth of experience behind our proprietary qsnFLOW™ methodology. Whether you’re preparing for an audit, launching a new product, or optimizing your quality systems, this is your trusted source for actionable, industry-specific knowledge that helps you reduce risk, ensure compliance, and drive operational excellence.
The Ins and Outs of Risk Management for Medical Device Manufacturing
Risk management is one of the most important parts of [...]
Stay Ahead of Regulatory Inspections with Gap Analysis
Regulatory inspections from the FDA are often nerve-wracking for a [...]
Redefining What a New Drug Really Is
New legislation was introduced in January of 2015 which seeks [...]
FDA Issues New Guidance on cGMP for Combination Products – A Quick Review
In January 2015 the FDA issued a new draft guidance [...]
Mobile Medical Apps and the FDA
For medical manufacturers, compliance with the FDA regulations is paramount, [...]
Delays in Biomanufacturing: What’s at the root of the problem?
Biomanufacturing is a difficult process, as anyone who works in [...]
