DDC – Boumans Regulatory Consulting

Quick due diligence checklist integral DDC

2022, December 14 by Ronald Boumans

Pharmaceutical companies that work together with a medical device supplier for their integral drug-device combination need to have sufficient control over the readiness of the required documentation. Especially in the early stages of a project, these matters can be challenging. The checklist can provide an indication of the readiness of the documentation for the device … Read more

Drug-device combinations need a specific MD department within a pharma company

2022, December 7 by Ronald Boumans

DDC There is a growing trend in the pharmaceutical field where we see companies not only develop their drug but also develop the device necessary to deliver the drug as intended. These drug-device combinations (DDC) come in various types and shapes: In some of these combinations, the device is considered to be a medical device … Read more