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.
Navigating the Complex Landscape of Combination Product Regulations
Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano [...]
Quality Solutions Now Turns 20!
Celebrating 20 Years of Excellence and Innovation! Twenty years ago, [...]
Announcing QSN and ComplyFDA Partnership!
Quality Solutions Now and ComplyFDA Partnership Leading the Way in [...]
ISO 13485:2016 rewrites the standard for medical device manufacturing
A risk-based approach to QMS. If you’re a manufacturer of [...]
Business continuity planning: vital to the life sciences industries
Business continuity planning (BCP) is essential for the success of [...]
Quality by Design paves the way for innovation
For companies in the Life Sciences industry, today’s climate—a mixture [...]