Proprietary Analytical Capabilities
Built from decades of real-world CMC experience and rigorous statistical methods. These proprietary tools are deployed directly in client engagements — delivering branded, citable reports with failure probabilities, sensitivity analyses, and regulatory interpretation built in.
Built for Real Decisions
These tools handle the quantitative heavy lifting — Monte Carlo simulation, USP stage logic, f₁/f₂ analysis — so every client conversation starts from data, not instinct.
When You Need More
Complex problems, tight specifications, or regulatory negotiations require deeper analysis. That is where Cachet Pharma Consulting adds its greatest value.
Built on Real Experience
Every tool reflects methods developed and validated through real CMC programs, regulatory submissions, and Agency negotiations over 30+ years.
Using your dissolution specification limits, process mean, and standard deviation, this tool runs a Monte Carlo analysis and returns the predicted probability of passing USP Stage 1, 2, or 3 — and the probability of batch failure. Every engagement includes a branded, citable PDF report with sensitivity analysis and strategic interpretation. Download a representative sample below.
Supports NLT, NMT, and Range specification types at multiple time points
Full USP Stage 1 / Stage 2 / Stage 3 testing logic applied to every simulated batch
Variability sensitivity analysis across a range of SD multipliers
Downloadable PDF report with consultant notes field for branded output
Best Used For
Quantifying batch failure risk before filing, evaluating the impact of FDA-proposed tighter specifications, and supporting ATP-driven method optimization decisions.
The f2 similarity factor is the FDA-accepted statistical measure for comparing dissolution profiles between a reference product and a reformulation, new strength, or post-approval change. This analysis is run with your actual mean dissolution values and delivered as a branded, citable PDF report with regulatory interpretation and strategic guidance. Download a representative sample below.
Calculates f2 per FDA and ICH guidance with automatic pass/fail determination
Visual overlay of reference and test dissolution profiles with fitted curves
Supports up to 12 time points with synchronized reference and test profile entry
Interpretation guidance aligned with FDA SUPAC and post-approval change requirements
Best Used For
Reformulation comparisons, scale-up and post-approval changes, new strength bridging, and 505(b)(2) reference product comparisons.
Tools in Development
A structured framework for evaluating and prioritizing development portfolios based on scientific, regulatory, and commercial criteria. A summary report outlining how a portfolio could be systematically optimized will be shared in Q3.
A data-driven approach to aligning scientific resources — personnel, budget, and capabilities — with strategic development priorities. Designed to help organizations maximize output and reduce inefficiency across complex R&D portfolios.
Moisture and oxygen permeability modeling for container closure selection and shelf life impact assessment.
Ready to Run This With Your Data?
The sample reports illustrate the format and depth of analysis. Every client engagement runs the simulation with your actual process data, your specification limits, and your regulatory context — and delivers interpretation you can bring directly into an Agency conversation. Read the dissolution specification case study or explore our full consulting capabilities.
Request a Technical ConsultationDisclaimer: These tools are provided for informational and educational purposes only. Monte Carlo simulations and f2 calculations are predictive in nature and should not be used as the sole basis for regulatory submissions or batch release decisions. Actual dissolution results may vary based on manufacturing conditions, analytical method variability, and environmental factors. Cachet Pharma Consulting, LLC assumes no liability for regulatory outcomes based on these models. For complex programs, regulatory negotiations, or submission-ready analyses, please contact us directly.