The New European Union MDR: Impact on Technical Files The following is the second in the series of blogs related to the recent updates to EU MDR The new MDR requires technical documentation to include...

Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence The following is the first in the series of blogs related to the recent updates to EU MDR Recent updates to the European Union...

Case Study: IDMP Proof-of-Concept Background: A global top 5 pharmaceutical company was looking to evaluate an IDMP solution including core application functionalities, complexities involved in curren...

Blog: Leveraging the Business-Process-as-a-Service (BPaaS) Model in Regulatory Affairs The Life Sciences industry has not yet fully leveraged the Business-Process-as-a-Service model (BPaaS) for Regula...