Case Study: Regulatory Intelligence Services to Support New Medical Device Registration in ROW Countries   Background – Client Need: An EU medical device manufacturer was looking to expand its ma...

Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR The following is the third in the series of blogs related to the recent updates to EU MDR Under the new EU Medical Device Regulation...

Case Study: Celegence Deploys Centre of Excellence Model to Streamline Regulatory Activities Client Need: Tackling regulatory activities A global biopharmaceutical company headquartered in France wa...

Celegence partners with Performance Development Group to help life sciences companies maximize their RIMS ROI                                                                       Strategic partnershi...

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...

Celegence and ArisGlobal Partner on RIMS and IDMP Business Process-as-a-Service Offering Strategic partnership between Celegence and ArisGlobal enables Life Sciences Companies to Leverage an Innovati...

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...