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.
Can the FDA keep pace with the science behind drugs and medical devices?
Understanding the science behind drug, biological and medical devices ensures [...]
How to Determine the Right Regulatory Path for Combination Products
Recent FDA reforms — such as the federal agency’s lean [...]
Will the FDA’s New Combination Products Policy Council Help with Key Decision-Making for Combination Products?
In March, the FDA spearheaded a lean management model that [...]
Will FDA Changes Lead to a Better Combination Products Review System?
You need to decipher ever-complex guidelines and a labyrinth of [...]
Is Human Factors Testing a Good Idea for Your Combination Product?
Effective management of use-related risks is crucial to ensuring the [...]
6 Steps to 21 CFR Part 4 Compliance for Your Combination Product
Combination products, made up of two or more components, have [...]
