By L. Parker, R. Dolan, and D. Treadaway, Clarkston Consulting
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 recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.
Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.
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.
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.
