Newsletter | November 10, 2025

11.10.25 -- What's In A Combination Product Development Lifecycle?

FEATURED EDITORIAL

What's In A Combination Product Development Lifecycle?

Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, lays out the phases and key activities in the development of a combination product or combination therapy. 

Design Controls For Drug Delivery Devices

In this article, DeGrazio underscores the importance of design controls in the development of combination products and other drug delivery devices. She explains foundational concepts and fundamental steps including design inputs and outputs, design verification and validation, design review, and change controls.

INDUSTRY INSIGHTS

Safely Navigating The Transition From MDD To MDR

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

Design-For-Manufacture Accelerates Device-To-Market

Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.

Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

This overview explores the benefits of PFS in biologic and vaccine delivery, the surge in demand driven by SARS-CoV-2, and the value of partnering with a flexible CDMO.

Innovative Softgel Technologies To Deliver Poorly Soluble Molecules

Learn how to expedite the development pathway for early phase compounds and how lipid based formulations provide an innovative approach to enhance bioavailability for challenging molecules.

Ensuring Effective Viral Vector Production

To develop a fruitful viral vector manufacturing process and a mutually beneficial relationship between sponsor and CDMO, one must balance cost, quality, and timeline via transparent communication.

Nanoformed API: A Superior Alternative To Solid Dispersions

Cutting-edge nanotechnology is now emerging, able to address bioavailability challenges and deliver higher drug loads in more patient-friendly formats with fewer and smaller pills and easier regimens.

SOLUTIONS

Finished Goods Capabilities For Drug Product Delivery

Transforming Drug Delivery

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