Stubbs & Hensel Pharma Consulting, LLC Email Format

Pharmaceutical ManufacturingPennsylvania, United States2-10 Employees

Stubbs & Hensel Pharma Consulting, LLC operates in the pharmaceutical manufacturing sector, providing specialized expertise in regulated bioanalysis to support drug development and regulatory submissions. The firm focuses on reducing regulatory risk during development and on guiding projects through regulatory processes, often working in concert with a bioanalytical CRO as project managers. Founded by partners with extensive real-world pharma and FDA experience, the company emphasizes proactive planning to anticipate and avoid issues that could delay filings or compromise compliance.

Based in Blue Bell, Pennsylvania, the organization comprises a small, specialized team. Its services target sponsors navigating complex regulatory pathways and seeking alignment with FDA expectations for bioanalytical programs. A notable development is the collaboration with the FDA to create the Stubbs & Hensel Electronic Data Audit Protocol, a proprietary approach used to perform over 75 forensic client audits at a major CRO, illustrating a focus on enhancing audit rigor and risk mitigation.

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