Newsletter | February 22, 2024

02.22.24 -- Analyzing & Kickstarting Organizational Quality Maturity


Getting Out Of The Doldrums: Analyzing And Kickstarting Organizational Quality Maturity

It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.

Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices And Biopharma

In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.


A Glass Package Designed Specifically For Pharmaceutical Use

A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.

Imaging Large Volume Subcutaneous Injections To Inform Clinical Design

New higher volume, higher viscosity pharmaceutical formulations for subcutaneous injection, alternatives to traditional intravenous treatment, enable chronic disease therapy in alternate settings.


Alvotech Announces Expected Global Market Entry Dates For AVT04 Biosimilar To Stelara® (ustekinumab)


Accelerated mAb Development Program

Combining Scientific Knowledge And Advanced Technology