Standards & Regulation

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.

With a no-deal Brexit still a real possibility, Merck continues to prepare for the worst case scenario.

Our animation explores the unique challenges a "no-deal" Brexit poses for the drug development and advanced therapy sectors.

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

Nominations are now open for The Medicine Maker 2020 Power List.

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

High quality excipients make all the difference to the drug development process. And yet, for years, excipients were often overlooked by the industry.

What are the consequences of allowing patients to purchase cell and gene therapies directly from hospitals?

Blockchain could be one solution to the saleable returns verification aspect of the US’ Drug Supply Chain Security Act.