Newsletter | November 7, 2024

11.07.24 -- Data Quality Issues At The Heart Of FDA's DSCSA Troubles

FEATURED EDITORIAL

Are You Considering Serialization Processes When Choosing A CDMO Or 3PL?

When choosing your trading partner (CDMO or 3PL), an important element that can be overlooked is serialization and DSCSA compliance. Ensuring these partners can meet requirements is critical.

CDER Wants Your Input On Improving Integrated Reviews

CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.

Data Quality Issues At The Heart Of FDA's DSCSA Troubles

Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

INDUSTRY INSIGHTS

How To Simplify Your Move From A Vial To A Prefilled Syringe

Explore market trends that could impact the lifecycle strategies for your drug product and its packaging. Careful selection of drug packaging can save time and support a successful transition to new formats.

Accelerating Your CHO Bulk Harvest Testing Using Rapid Methods

With advanced rapid methods that offer both speed and sensitivity, you can expedite your bulk harvest testing and detect adventitious viruses in half the time compared to conventional techniques.

SOLUTIONS

A Single-Use Chromatography System For Scale-Up And GMP Manufacturing

Combining Scientific Knowledge And Advanced Technology