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RegulatoryRegulatory
We’ve got your back. Developing strategies, representing sponsors, and writing and submitting filings to regulatory authorities is our bread and butter.
Program Launch and Phase 1 Trial Management
An innovative biotechnology company that uses stem cell science needed regulatory and clinical operations guidance for launching their first Phase 1 Trial program.- Read more about Program Launch and Phase 1 Trial Management
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ClinicalClinical
Thousands of operational details must be managed to ensure your development programs deliver results. We keep your strategies moving and under control.
Clinical Development Plan Support
Biopharmaceutical company developing a revolutionary class of drugs using novel technologies was transitioning their lead compound from research to development and needed clinical leadership to drive program development, planning, and execution.- Read more about Clinical Development Plan Support
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Interim Management & ExpertiseInterim Management & Expertise
When a critical skillset is missing, we fill in the gaps to keep the program chugging along.
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.- Read more about On-Demand Development Team
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Meet the Build team leads
Katie McCarthy
Lyn Agostinelli, RN, BSN
Susan Gould, MS, MBA
Jason Milovanovic
Kim Raymer
Keri Urwin, MBA