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DeepC Safety Agents: PDE, OEL, E&L and Nitrosamine Assessments

  • DeepC Safety Agents: PDE, OEL, E&L and Nitrosamine Assessments 1
  • DeepC Safety Agents: PDE, OEL, E&L and Nitrosamine Assessments 2
  • DeepC Safety Agents: PDE, OEL, E&L and Nitrosamine Assessments 3
Product Description

Produce dossier-ready safety assessments in minutes. Specialist agents cover permitted daily exposure (PDE/ADE) monographs, occupational exposure limits (OEL), extractables and leachables risk assessments, nitrosamine risk evaluation and environmental risk assessment (ERA), each anchored to ICH, EMA, FDA and PQRI frameworks with full citation trails. DeepC retrieves the toxicology, clinical and regulatory evidence, derives thresholds using read-across and standard uncertainty factors, and presents output in the structure reviewers expect. Built for toxicology, quality and regulatory teams that need defensible documents, not raw search results. We know your IP is everything. So is keeping it yours: single-tenant VPC, customer-managed encryption, 21 CFR Part 11-aligned audit log. Your data is never used to train our models. deepceutix.com

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DeepCeutix

  • Country/Region:
    United Kingdom
  • Founded:
    2025
  • On CPHI since:
    2026
  • Employees:
    1 - 24
Company types
Start-up
Primary activities
Technology
View company profile
Categories
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Specifications
  • Details
    Specifications
    • Specialist agents: PDE/ADE, OEL with OEB tier, Extractables, Leachables, Nitrosamines, ERA
    • Five-phase method: evidence retrieval, read-across, explicit threshold arithmetic, Klimisch-tiered citations, framework-structured PDF with QP sign-off block
    • Anchored to ICH M7(R2), ICH Q3E, EMA HBEL, EMA Appendix 1, USP <1663>/<1664>, PQRI PODP, ECETOC TR 101, EMA ERA Rev. 1
    • Sources: ECHA REACH IUCLID, EFSA OpenFoodTox, JECFA, EPA IRIS and CompTox, NIOSH, OSHA, GESTIS
    Application areas
    • Cleaning validation PDE/HBEL; HPAPI containment banding
    • Container closure and single-use extractables and leachables
    • NDSRI acceptable intake and CPCA category; control strategy
    • Environmental risk assessment for MAA/NDA; toxicology, QA and regulatory dossier preparation
  • Selling Points
    Convenience; Product Features; Product Performance; Quality Service;
    • Dossier-ready structure that reviewers expect
    • Every safety factor shown as explicit arithmetic
    • Klimisch-tiered references with study narratives
    • Read-across when direct data is missing
    • Live demos at CPHI Milan 2026, Hall 8, stand 8S72, 6 to 8 October
    • deepceutix.com
  • Supplied from
    United Kingdom
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Sales Markets
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DeepCeutix

  • Country/Region:
    United Kingdom
  • Founded:
    2025
  • On CPHI since:
    2026
  • Employees:
    1 - 24
Company types
Start-up
Primary activities
Technology
View company profile

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