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Provider type:

CMC, Process Validation, CMO Management

Limited

Nearly 10 years in life sciences across CMC and operations. Expert in scale‑up, validation, and vendor/CMO management for biologics.

CMCProcess ValidationVendor ManagementProgram Leadership

Former FDA (CDER/CDRH/CBER) • Regulatory Strategy

Available now

8 years at FDA with submissions in CDRH, CDER, and CBER. Advises on IND readiness, briefing packages, and cross‑functional alignment.

RegulatoryFDA MeetingsQualityModule 3

Analytical Development • Bioassay

Available now

Analytical method development and validation for biologics. Deep experience in impurity assays (HCP/DNA) and ICH Q5C stability programs.

AnalyticalELISAHCPStability

Non‑clinical & Translational

Booked

Designs pragmatic GLP tox strategies and translational plans that de‑risk first‑in‑human studies and IND reviews.

Non‑clinicalToxPK/PDTranslational