Posts Tagged ‘combination products’

Tips for Hiring Specialty Expertise Consultants

Outsourcing with Confidence: A Guide to Successfully Hiring Specialty Expertise Consultants in Healthcare

Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and combination products are turning to external consultants with specialized expertise and a deep understanding of ever-changing quality regulations. This approach allows these companies to supplement their internal teams cost-effectively. Read more »

Your Guide to the 2024 Combination Products Summit: Agenda, Insights, and What to Anticipate

Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination Products Summit is the premier event where industry leaders, regulators, and experts come together to tackle these challenges head-on.

This year’s summit promises to be more impactful than ever, offering a comprehensive agenda that will equip professionals with the knowledge and tools they need to navigate the complexities of combination products in a dynamic regulatory environment.

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Navigating the Complex Landscape of Combination Product Regulations

Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano spoke at the Combination Products Summit. Source: Michele G. Sullivan

Insights From Combination Products Summit

The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because different countries have their own definitions and requirements for these products. This lack of uniformity complicates the application process, adding layers of complexity and burdening manufacturers. Read more »

Quality Solutions Now Turns 20!

Celebrating 20 Years of Excellence and Innovation!

Twenty years ago, Quality Solutions Now (QSN) embarked on a mission to create a world where health is protected and promoted through the manufacturing of safe and effective medical products. From our humble beginnings in October 2004, QSN has seen tremendous growth, now serving a diverse range of clients in the medical device, drug, and biologic manufacturing sectors.

As we celebrate our 20th anniversary, we reflect on our journey and the remarkable milestones we’ve achieved. Here’s a look at our progress:  Read more »

Announcing QSN and ComplyFDA Partnership!

Quality Solutions Now and ComplyFDA Partnership

Leading the Way in Life Sciences Compliance and Quality Management

Quality Solutions Now (QSN) and ComplyFDA have joined forces to offer unparalleled solutions in quality management and regulatory compliance for the life sciences industry. This collaboration enhances our capabilities in providing comprehensive, scalable, and cost-effective solutions, ensuring clients meet and exceed quality and regulatory standards. Read more »