FDA Experience

FDA GLP (21CFR, Part 58) experience includes working with Pharmaceutical, Biotechnology and Medical Device companies. Specific study and facility related experience includes:

Preclinical safety studies conducted with small molecules, biologics and medical devices including combination products.
Bioanalytical and biomarker assays including those conducted using LC/MS/MS, ELISA, qPCR, flow cytometry
Test article characterization and dose concentration analysis
Review of IND/NDA preclinical sections
Clinical trial support analyses and activities including bioanalytical, histopathology and flow cytometry
Animal Rule studies
Assay validation
Software validation
Statistical analysis