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.
Combination Products: Can Partnerships Between Drug and Device Companies Streamline Efficiencies?
The drug-device combination market is booming. On track to generate [...]
The Anatomy of an Effective Project Charter
Projects move innovations from concept to commercialization. They can be [...]
Six Sigma DMADV Method – Is It Worth The Trouble?
Six Sigma is a set of strategies that focuses on [...]
How to Successfully Manage Your Medical Device Design History File
The launch of a new medical device is a time [...]
Meeting the Regulatory and Manufacturing Challenges of Modern Sterile Product Packaging
In the realm of drug manufacturing, sterile products continue to [...]
Executing Successful Large-Scale Change
Over the next few years, the global combination products market [...]