ABOUT
Independent Expertise in Environmental Fate, Metabolism & Residue Chemistry
Marian Ponte brings more than 33 years of hands‑on laboratory and regulatory experience designing, interpreting, and defending GLP studies for global registration including EPA/OCSPP, CVM, EU and OECD, PMRA, JMAFF, and IBAMA/ANVISA frameworks. Her work spans environmental fate, metabolism, residue chemistry, and complex study packages requiring senior‑level scientific judgment.
Her career includes leadership roles in industry, oversight of global study programs, and direct engagement with regulatory authorities. She is known for her ability to translate complex chemistry into clear, defensible scientific narratives that withstand regulatory scrutiny.
Professional Background
- 33+ years expertise in the fields of environmental fate, metabolism, and residue chemistry
- Extensive experience with US EPA OCSPP, CVM, Canada PMRA, EU REACH, EFSA, and OECD, Japan JMAFF, Brazil IBAMA/ANVISA guidelines
- Leadership roles in novel approaches in study design, data interpretation, and dossier preparation
- Excellent oral and written skills, 200+ scientific regulatory reports, regulatory agency communications, published journal articles, national and international scientific conference presentations
- Proven track record resolving data gaps and troubleshooting complex chemistries
- Mentor to Study Directors, GLP compliance and early‑career technical staff
Approach
Marian’s consulting is grounded in scientific rigor, regulatory alignment, and practical execution. She works collaboratively with teams to build defensible study packages, anticipate reviewer questions, and streamline the path to submission.
Mission
To provide independent, senior‑level scientific and regulatory expertise that strengthens study programs, accelerates submissions, and builds internal capability for long‑term success.