Clinical Process Roadmap

A global medical device company with clinical operations staff in multiple locations that had grown through acquisitions wanted to harmonize their SOPs into a single repository.
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Warning Letter Remediation

A global medical device company received repeat 483s and a Warning letter from the FDA. Halloran provided immediate expert regulatory and quality leadership overseeing interactions with the agency, remediation, and correction of 50+ findings.
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On-Demand Development Team

A completely virtual biotech company initially needed a partner to advise them on the drug development process and development planning. The relationship continued to expand as development progressed.
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