BayesPK Generics

ANDA Evidence Intelligence OS
Checking platform Program OS Regulatory-ready Audit trail Guided workflow
Generic Product Development Intelligence

ANDA Strategy Command Center

Convert a target molecule into a clear development decision: RLD reverse engineering, formulation sameness, product-specific guidance, bioequivalence planning, patent and launch strategy, lab work, analytical validation, submission readiness, portfolio priority and report generation.

RLD → ANDAend-to-end evidence workflow
BE Strategysample size, sensitivity and study risk
Patent Launchchallenge, wait, license or design-around
Board Reportdecision-ready dossier output
Opportunity score
—
Run assessment
Submission readiness
—
Stage gate
Evidence issues
—
Highest risk
Regulatory clarity
—
Pathway confidence
BE probability
—
Study design
Launch feasibility
—
Patent feasibility

Boardroom Decision

Decision, rationale, risks and stage-gate recommendation.
not assessed
Run Full Product Assessment to generate a decision.

Next Gate

What the team should do before the next investment decision.
actionable

RLD & Sameness

Formulation target space and Q1/Q2/Q3 status.

Evidence Gaps

Top blockers before the next stage.

Best Launch Path

Risk-adjusted strategy option.

Guided Workflow

From molecule triage to submission package.

Stage-Gate Action Board

Regulatory, formulation, BE, analytical, patent and commercial workstreams.
pending

Evidence Map

How scientific, regulatory, patent and commercial evidence connects.

Evidence Reconciliation

Flags contradictory or incomplete evidence.

Source Confidence

Data availability and confidence across connected intelligence sources.

Product-Specific Guidance

Regulatory pathway, waiver strategy and study expectations.

Regulatory Gap Map

High-impact regulatory gaps before BE protocol lock.

FDA Interaction Strategy

Meeting need, packet and owner map.

Agency Question Builder

Structured questions and submission checklist.

BE Study Simulator

Sample size, dropout adjustment, pass probability and study risks.

BE Sensitivity

CV, T/R ratio and sample-size sensitivity.

Dissolution Similarity

f2 comparison for in vitro performance.

BE Confidence Interval Check

Checks whether 90% CI assumptions fit the expected window.

RLD Lab Plan

Assays, techniques, sample strategy and priorities.

Analytical Method Plan

Assay, dissolution, excipient quantitation, PSD and solid-state methods.

Validation Matrix

Specificity, accuracy, precision, linearity, robustness and documentation.

Prototype Design Plan

CQA/CPP factors, responses and batch plan.

Patent Estate

Patent classes, challenge difficulty and strategy.

Launch Scenarios

Wait, challenge, settlement, design-around or avoid/watch.

Scenario Simulator

Readiness-adjusted value and portfolio decision.

Portfolio Ranking

Prioritize multiple generic opportunities.

Molecule Comparison

Compare two opportunities side by side.

Management Report

Decision memo, regulatory plan, patent strategy, lab plan and readiness summary.

Public Evidence Links

Regulatory and public source links for follow-up review.
BayesPK Generics is a decision-support system. Confirm with measured RLD lab work, validated BE statistics, CMC/regulatory review and patent counsel.
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