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.
If you fail to plan, plan to fail
We’ve all heard this saying, right? Sometimes though, it takes [...]
A changing perspective
Perspective…we all have one, but have you ever had an [...]
Why Is There a Divide Between Scientists and Engineers?
Few disciplines are as closely related as science and engineering [...]
The Facts About Combination Product Regulation and Risk Management
Combination products offer novel or improved treatment options, but can [...]
How to Determine a Combination Product’s Primary Mode of Action
Combination products raise distinct regulatory challenges because they comprise two [...]
Will the FDA’s Intercenter Pilot Project Improve the Combination Product Submission Review Process?
Combination products present regulatory challenges because their constituent parts must be [...]