DISCOVERY
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innovations during the drug
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innovations during the drug
discovery phase.
Halloran’s Ecosystem Gathers to Improve Clinical Development Operations
Clinical development and operations executives and life science leaders recently gathered ...
EU MDR Compliance – Why Is Our Industry Still Struggling?
The European (EU) Medical Device Regulation (MDR), adopted in 2017, was a sizeable update ...
Cell and Gene Therapy Development – Three Key Challenges in 2023
About 50 years elapsed from when Rogers and Pfuderer provided the initial ...
Reimagining Clinical Studies to Support Accelerated Approvals
There is, and always has been, a need for speed in drug development. While, in many ways, ...
Establishing a Culture of Quality: What Every CMO Should Know
Leaders at biopharma companies often ask us, “What is a culture of quality and how do you ...
A Successful Pre-IND Enabling Next Stage of Development
Regulatory Case Study Pre IND DOWNLOAD THE CASE STUDY
Halloran Opens Second Office in San Diego
“Halloran Opens Second Office in San Diego” was originally published on Contract Pharma. ...
Early Collaboration with FDA for Novel Programs: Maximizing the Emerging Technology Program (ETP)
Established in 2014, the U.S. Food and Drug Administration’s (FDA) Emerging Technology ...
FDA Issues Final Guidance About Multiple Endpoints in Clinical Trials
On October 21, 2022, the U.S. Food and Drug Administration (FDA) issued the “Multiple ...
Aligning Your Clinical Operating Model – a Case Study by CSL Behring
CONTENT IN COLLABORATION WITH CSL BEHRING Valerie Reynaert, Head of Global Clinical ...