Forced-degradation profiling, ICH Q1E shelf-life evaluation, ICH M7 toxicology, a full ICH Q3 impurity limits calculator, QbD design-of-experiments with an ICH Q8 design space, ICH Q14 analytical method development & risk assessment, HED/MRSD dose scaling, PDE/ADE/OEL cleaning-validation limits, plus a chromatography suite — column selectivity and chromatogram prediction — and RegIntel, a citation-grounded assistant across ICH, 21 CFR and FDA sources — all driven by transparent, validated chemistry.
Computationally simulate hydrolytic, oxidative, photolytic, and thermal stress. Map complete degradation pathways and generate MS fragmentation profiles to accelerate stability-indicating method (SIM) development.
Execute a compliant dual-methodology (Expert Rule + Statistical QSAR) mutagenicity hazard assessment. Automatically calculate FDA CPCA nitrosamine scores, acceptable-intake limits, and empirical read-across data.
Evaluate long-term stability data with the statistical rigor regulators expect — or predict shelf-life early from accelerated stress data. The analyzer runs two modes: an ICH Q1E regression with the one-sided 95% lower confidence bound, and a moisture-modified Arrhenius fit that extrapolates accelerated (e.g. 40°C/75%RH) kinetics to your storage conditions.
Enter a single maximum daily dose and route of administration to instantly generate every applicable ICH Q3 threshold — organic impurity limits, residual solvent PDEs, elemental impurity PDEs, and the extractables analytical evaluation threshold (AET).
Compare two dissolution profiles the way a regulator does. Compute the f2 similarity and f1 difference factors, enforce the 85% rule and RSD eligibility checks, and — when variability is too high for a direct f2 — run a bootstrap 90% confidence interval of f2. Supplementary Weibull / first-order / Higuchi / Korsmeyer-Peppas fits characterise the release kinetics.
Predict reversed-phase chromatograms and elution order for a set of molecules — pulled straight from a degradation run or entered as SMILES. Scout a standardized grid of columns, mobile phases and pH, rank every condition by resolution of the critical pair, and get a recommended UV detection wavelength.
Compare reversed-phase HPLC columns objectively with the published Hydrophobic-Subtraction Model — rank equivalents and flag non-interchangeable columns before you re-validate a method or qualify a second supplier.
Design an experiment, fit a response-surface model, and map the ICH Q8(R2) design space — the multivariate region where every response stays in specification — with a Monte-Carlo edge of failure. The QbD workflow scientists return to for every formulation, process step or method they optimize.
The everyday QC-lab calculations, done right and free in the browser — five compendial calculators in one place, computed locally with nothing uploaded. The tool analysts open every day.
Convert an animal dose to the Human Equivalent Dose using the FDA body-surface-area Km ratio, then derive the Maximum Recommended Starting Dose for a first-in-human trial — the calculation toxicologists reach for constantly.
Derive the Permitted / Acceptable Daily Exposure, Occupational Exposure Limit and OEB band from a NOAEL — the backbone of cleaning validation and shared-facility risk assessment for CDMOs. Includes an optional MACO carryover limit.
Define an Analytical Target Profile, run a formal FMEA risk assessment with live RPN traffic-lights, screen robustness against the Method Operable Design Region, and generate an audit-ready, SHA-256-stamped risk-control-strategy report — the ICH Q14 workflow, from intent to control strategy.
A citation-grounded regulatory assistant. Ask a question and get an answer drawn from the source documents themselves — with the exact, verbatim passage and reference behind every answer. No hallucinated citations, no guessing: if the corpus doesn't cover it, RegIntel says so.
Submit a structure (SMILES) or paste your stability timepoints and specification limits.
Deterministic rules, QSAR engines, and ICH Q1E regression run in a single pipeline.
Guard-railed AI drafts a plain-language interpretation from the computed facts only.
Export an audit-ready PDF for a qualified reviewer to check, edit, and sign.
Run your first in silico assessment free and see the regulatory-grade output for yourself.