Newsletter | June 13, 2022

06.13.22 -- Patient-Centric Drug Delivery Focused On Quality And Regulatory Standards

Trends In Combination Products

As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug-device combination products.

Quality By Design And Design Control Roadmap For Combination Products

Quality by design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability.

Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

Container Closure Integrity: A Risk-Based Approach

Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

Minimizing Uncertainty Throughout The Development Life Cycle

Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.

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