Resources

As combination products, such as prefilled syringes, auto-injectors, and drug-device kits, become more prevalent, pharmaceutical and biologic companies must adapt their existing Quality Management Systems (QMS) to meet regulatory expectations...

As connected medical devices become more prevalent, cybersecurity regulations are evolving rapidly across global markets. Manufacturers must now navigate complex requirements from both the United States Food and Drug Administration...

With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This whitepaper offers a focused look at preparing your facility, emphasizing internal audits and...

This white paper presents a detailed roadmap for compounding pharmacies aiming to transition from a 503A patient-specific model to a 503B outsourcing facility. It explores the strategic planning, facility design,...

Regulatory Compliance Associates (RCA), a Nelson Labs company, along with Sterigenics and Nelson Labs, part of Sotera Health, offer an integrated suite of services tailored for wearable and implantable connected...

In today’s connected healthcare landscape, cybersecurity is not just a technical requirement, it’s a strategic investment. For medical device manufacturers, early planning can significantly reduce cybersecurity costs while improving compliance,...