Practice 04 · Expert-led consulting
Pharmaceuticals
Expert-led pharmaceutical toxicology and impurity science.
Consulting on pharmaceutical impurity risk, occupational exposure limits, nitrosamine assessment, and toxicological support for drug development. Expert-led — not automated software capabilities.
Services
What Aᴳ delivers.
- PDE Derivation
- Occupational Exposure Limit (OEL) Support
- ICH M7 Scientific Review
- Nitrosamine Risk Assessment
- Impurity Qualification
- Pharmaceutical Toxicology
- Extractables & Leachables Review
- Occupational Toxicology
Industries served
- — Drug Products
- — Drug Substances
- — Manufacturing
- — Pharmaceutical Development
Applicable regulations
- — ICH M7
- — ICH Q3A/B/C/D
- — EMA PDE Guideline
- — USP <232>/<233>
- — OSHA
Related ToxIntel capability
ICH M7 & PDE workflow templates
ToxIntel is Aᴳ’s enterprise scientific safety intelligence platform — a distinct product that supports, but does not replace, the consulting practice.
Engage the practice
Talk to an independent toxicologist about your pharmaceuticals question.
Send a short brief — product, jurisdictions, timeline, and the scientific question that prompted the call. We respond within two business days.