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