GuidanceStatby Estatística Digital

Regulated Study Planning Platform for Life Sciences

From regulatory question to defensible study design — without forcing you to become a statistician.

GuidanceStat turns FDA and ANVISA guidance into guided workflows. You state the regulated decision you need to make; GuidanceStat applies the guidance, runs the statistics underneath, tells you what drives the risk, and hands you a decision with the justification your reviewers and regulators will read.

Talk to the GuidanceStat team See the Regulatory Jobs

The problem

Guidance tells you what to demonstrate. It rarely tells you how to get there.

Regulatory guidance describes acceptance criteria, conditions and decision rules. Turning them into a study design or a shelf-life claim still means translating the guidance into a statistical method, building the analysis, applying the regulatory rules by hand, and writing up why the result holds. That translation usually waits on a statistician, lives in spreadsheets or one-off scripts, and is hard to reproduce or audit later.

GuidanceStat removes the translation step. You work in the terms of the guidance; the statistics stay underneath, and every number traces back to the rule or the data that produced it.

The platform

How GuidanceStat works

Start from the regulatory job, not from the statistical method.

Regulatory Jobs: You enter through the job you need done, such as “design my pivotal IVPT study” or “establish my shelf life”, not through a statistical method.
Guidance Packs: Each job runs on a versioned pack of the applicable guidance. Every parameter shows its source and its force: binding regulation, guidance recommendation, or a product default you may change with a recorded justification.
A diagnosis, not just a number: GuidanceStat explains why a design needs its size and which lever actually changes the risk. Sometimes the answer is to revisit the formulation, not to enlarge the study.
Your decisions, recorded: Where the guidance leaves a judgment to you, GuidanceStat asks for it, records your justification, and prints it in the report. It never makes that call for you.
A justification you can submit: Each result comes with a generated Justification Document that states the method, the assumptions, the rule applied and the reason for the outcome.
Reproducible by design: The same data, decisions, guidance pack and engine release always give the same result. Your Project File lets anyone reproduce or verify it later.
Verified engines: Each calculation engine is checked against the examples published by the regulator and against independent statistical references before release, and every release is immutable.

Coverage

Regulatory Jobs

We add Regulatory Jobs one at a time. Each has its own guidance packs, its own verified engine and its own qualification evidence.

· IVPTAvailable

IVPT pivotal study design

FDA guidance on In Vitro Permeation Test studies for topical products (draft, October 2022)

Plan the pivotal in vitro permeation test for a topical generic from your pilot data. GuidanceStat estimates the variability in your pilot, simulates the full FDA acceptance procedure across candidate numbers of donors and skin sections, and recommends a design with its Joint Passing Rate (the probability that both required endpoints pass) and its cost.

It also diagnoses the design. Is the risk driven by precision, by variability, or by the expected test-to-reference ratio? If it is the expected ratio, adding donors may not help, and GuidanceStat says so:

Design diagnosis

“The limiting factor is expected T/R behavior, not statistical precision.”

You bring: Pilot IVPT data (CSV or spreadsheet), your target passing probability, and optional cost inputs.
You get: A recommended donor and section design, the Passing Rate Matrix behind it, the design diagnosis, a sensitivity table, alternatives with their cost, a Justification Document and a reproducible Project File.
Verified against: The worked examples published in the FDA guidance (balanced and unbalanced cases), and statistical functions checked against an independent reference implementation.

· StabilityIn development

Stability: shelf-life planning and evaluation

FDA: ICH Q1A(R2), Q1D, Q1E; FDA guidance and Q&A on ANDA stability testing · ANVISA: RDC 318/2019, Guide 28/2019

Plan a stability program for the US, for Brazil, or for both, then turn the results you collect into a shelf life you can defend, with the report generated for you.

01
Plan. Storage conditions per jurisdiction, including 30 °C / 75% RH for Brazil, pull schedules, filing milestones and sample quantities. A data-entry template is generated from your protocol.
02
Import. Results by batch, condition, attribute and time point, with every exclusion kept and explained.
03
Analyze. Significant-change and out-of-trend screening, regression and batch poolability as described in ICH Q1E, and the 95% confidence limit for the mean against your acceptance criteria.
04
Decide and report. The ICH Q1E extrapolation decision tree and the ANDA approval limits for FDA; the provisional shelf-life rules of RDC 318 and Guide 28 for ANVISA. Reports in English for Module 3 and in Portuguese for ANVISA.

For dual-market programs, the FDA and ANVISA evaluations run side by side on the same data and are never merged into a single verdict.

· IVRTPlanned

IVRT: in vitro release testing

FDA guidance on In Vitro Release Test studies for topical products (draft, October 2022)

Support for planning and evaluating in vitro release studies for topical generics, from method validation to the pivotal release-rate comparison. We are building the regulatory foundation for this job now; its scope will be confirmed as the guidance and its referenced compendial methods are finalized.

Tell us

Your next Regulatory Job

We choose the next job by what customers need. Areas we are exploring include bioequivalence study planning. If a guidance-driven study decision takes your team weeks, we would like to hear about it.

Tell us about it

Why teams buy it

One platform, a different reason to buy for each team

CROs and specialized labs

Capacity

Turn pilot data into defensible study plans faster, with fewer handcrafted biostatistics hours per study.

Pharma

Risk reduction

Reduce the risk of committing to the wrong regulated study design, and reach a defensible protocol sooner.

Biostatistics

Leverage

Automate the standard cases and keep specialist time for the exceptions, with every assumption and intermediate result open for review.

Quality assurance

Less qualification effort

Adopt a reproducible, versioned engine with explicit release evidence instead of a black-box calculator.

Who it is for

Built for the people who own the regulatory decision

RoleWhat GuidanceStat changes

Study planners and CMC leadsPlan and evaluate studies in the terms of the guidance, without waiting for a custom analysis.

StatisticiansReview the method, the assumptions and every intermediate result instead of rebuilding the analysis for each product.

Regulatory affairsReceive a generated justification, tables and plots ready to adapt for the dossier.

Quality assuranceAssess a release with its verification evidence instead of starting a validation project from nothing.

Trust

Your data stays with you

Your raw study data is processed in your browser. It is never uploaded to our servers.
Only the derived values a calculation needs (for example, summary statistics) reach our protected engine, over an authenticated connection. The engine does not store or log them.
There is no hosted project storage. Your work lives in a Project File that you keep.
Every server-computed result carries a signed proof, so you can later verify which engine release produced it.

For very short data series, summary statistics can reveal individual values. Our intended-use documentation describes exactly what leaves the browser for each job.

Evidence your QA team can assess

Immutable engine releases, each with a Release Verification Report that states what was verified and against what.
Qualification against regulator-published examples where they exist, and against independent statistical references where they do not. The strength of the evidence is labelled for each check.
An integrity check on every load, and an explicit error instead of a silent fallback when something is wrong.
A supplier evidence pack to support your own risk-based assessment of the tool.

GuidanceStat does not claim a GAMP category or a validation status for your use. Those are your organization's risk-based determinations, and our documentation is built to support them.

Limits

What GuidanceStat does not do

It does not predict or guarantee acceptance by FDA, ANVISA or any other agency. It shows the maximum the guidance permits and the reasoning behind it.
It is not a LIMS or system of record. Your stability results and study records stay in your own systems.
It does not make judgments the guidance leaves to you, and it does not notify regulators on your behalf.

Talk to us

Tell us which regulatory decision your team needs to make.

The IVPT job is available today. For stability and IVRT, we want to hear how your team handles the problem now. If your case is a different one, tell us too: that is how we choose the next Regulatory Job.