Quality & Compliance

What are the most important things to consider when filing an IND? This infographic, sponsored by Regis, sets out the five key steps to success.

GDUFA fees for 2020 have been decided – and include a significant drop in the fees for finished dosage facilities.

Fail to Prepare? Prepare to Fail…

Viral contamination can shut down a plant for months – affecting manufacturing, causing business disruption and threatening supply and patient safety.

Qualitative risk assessments are a great way to approach quality management and train your operators at the same time.

By simulating processes in a digital twin of a facility, changes can be safely tested before application in the real world.

As a leading partner and supplier to the industry, MilliporeSigma continues to strengthen and enhance its supply chain capabilities.

Viral contamination can have devastating effects. But innovations upstream can help prevent that.

Helping to meet demands and reduce shortages... Is continuous manufacturing the way forward for pharma?

Sitting Down With... David Schoneker, Global Regulatory Director, Strategic Relationships at Colorcon.