Resources

Quality Metrics: Optimizing Your QMS to be FDA compliant. This FDAnews virtual summit webinar can empower your team to develop a world-class QMS by implementing the essentials of quality management...

The 505(b)(2) regulatory pathway provides a framework for sponsors to reformulate existing immediate-release drugs into extended-release versions, utilizing existing data to streamline the approval process. Key insights are presented on...

Outsourcing has become an increasingly common practice in the life science industry, and more companies are turning to outsourcing to manage operations and tactical skills, and also help adopt best...

In today’s competitive business environment, emerging life science companies run lean, particularly in terms of personnel. However, the complexities of the quality (QA) function in medical devices require the highest...

Are You Ready for New Approaches and Methods? In this FDA News hosted webinar. Regulatory Compliance Associates®, Seyed Khorashahi, Executive Vice President and CTO, shares the most likely medical device...

Regulatory audits and compliance assessments are essential in identifying product, process and system deficiencies, risk assessment, and inspection readiness. Our FDA veterans and industry consultants use a risk-based approach to...