One controlled path from reference product to ANDA readiness.
Connect RLD intelligence, formulation, scale-up, bioequivalence, quality, and filing evidence in one reviewable program record.
Same evidence for every role and artifactNo more reconciling version-stamped PDFs between teams.
Reasoning carried from RLD to Module 3Decisions, assumptions, and rationale stay linked.
Built around FDA and ICH sourcesOrange Book, PSG, dissolution, and stability guidance in one spine.
Phase 1 feature entries
Open the new evidence work without leaving the operating record.
These entry points start in the ANDA Intelligence Board and save back into Program OS, so source posture, CMC narrative, and board summaries stay tied to the same program record.
FDA / PSG / Orange Book
Watch official source movement before packet lock.
Track PSG, Orange Book, labeling, and guidance changes with owner, source, confidence, and next action.
Module 3 evidenceCompose CMC narrative sections from controlled rationale.
Draft quality, formulation, analytical, stability, and manufacturing sections with gaps and reviewer posture visible.
Decision packet exportTurn Program OS evidence into board and regulatory summaries.
Export a decision packet and save the packet state back to the active program for follow-up review.
Role-based entry
Start from the job each team needs to finish.
Every role sees the same controlled program record, but starts from a different operational question. These lanes reduce browsing and route each user toward the right evidence, source, review, and packet workflow.
Program Lead
Coordinate the whole ANDA path.
Monitor readiness, stage gates, owners, source freshness, document packet state, and the next controlled action.
RegulatoryMake the submission story reviewable.
Connect PSG posture, eCTD preflight, correspondence, deficiency risk, and agency-facing packet readiness.
CMC / QAControl Module 3 and quality evidence.
Keep formulation rationale, process controls, stability, QMS, and reviewer signoff aligned before packet lock.
BEConnect performance to risk decisions.
Review dissolution, f2, IVIVC, BE confidence, study interpretation, and response evidence in one trail.
ExecutiveSee readiness, risk, and economics.
Inspect portfolio value, launch timing, margin sensitivity, deficiency exposure, and board-ready decisions.
Start in the right workspace
Choose the decision lane, then carry the result forward.
The homepage works as a triage layer: start with the scientific, regulatory, or commercial uncertainty, open the right module, then preserve the output inside the Program OS evidence spine.
Decision launch map
Open Program OS
Move from a question to a defensible next action.
Use the homepage as a triage layer: choose the scientific or commercial uncertainty, open the right module, then carry the output into the ANDA evidence trail.
What is the ANDA execution engine?
Create master data, lock evidence, monitor FDA source freshness, build eCTD preflights, author Module 3 sections, govern AI outputs, manage correspondence, and prioritize the portfolio.
Evidence spineOpen Generics Program OS
Should we select this product?
Compare market pressure, patent risk, reference complexity, evidence burden, and target margin before development spend.
PortfolioOpen portfolio selection
What does the RLD tell us?
Structure RLD observations, reverse-engineering hypotheses, Q1/Q2 strategy, and formulation constraints.
FormulationOpen reverse engineering
Which formulation tradeoff is safest?
Explore dissolution, excipient, process, and cost tradeoffs before locking a development formula.
FormulationOpen QbD safe space
Will the product survive scale-up?
Review process sensitivity, yield, equipment fit, transfer risk, and validation readiness.
ManufacturingOpen scale-up risk
Is the ANDA story reviewable?
Control PSG/source posture, evidence readiness, Module 3, eCTD QC, correspondence triage, patent timing, and lifecycle handoffs.
EvidenceOpen regulatory control tower
Reduce the expensive iterations, not the scientific rigor.
Generic development becomes costly when formulation, manufacturing, quality, and regulatory decisions are reviewed too late or in isolation. BayesPK helps teams compare tradeoffs while changes are still affordable.
Prioritize before development spendInclude complexity and evidence burden in product-selection decisions.
Optimize cost with performanceCompare material, process, yield, and dissolution implications together.
Reuse the evidence chainCarry development rationale into reviews, transfer, and submission preparation.
Illustrative cost of discovering risk lateRelative burden index
Illustrative product-positioning model. Actual cost depends on product complexity, studies, manufacturing scale, regulatory pathway, and internal processes.
ANDA evidence spine
Keep the scientific argument connected from first screen to final packet.
The strongest generic programs do not treat portfolio, formulation, BE, quality, and submission work as separate stories. This pathway makes the handoffs explicit.
Program master data
Product identity, RLD basis, filing strategy, owners, target margin, reviewers, and controlled program context.
Open Program OSQTPP and material understanding
API, solid state, excipient roles, RLD observations, critical attributes, and similarity hypotheses.
Open characterizationFormula and design space
Candidate compositions, process choices, dissolution targets, cost impact, and QbD rationale.
Open formulation hubProcess and scale-up control
Equipment fit, CPP sensitivity, yield, validation readiness, transfer package, and BMR preparation.
Open scale-up riskPerformance and BE package
f2, biorelevant dissolution, IVIVC context, BE confidence, study interpretation, and residual risk.
Open BE dashboardSubmission and lifecycle
Source posture, Module 3 narrative, stability, quality events, eCTD preflight, regulatory milestones, post-approval changes, and commitments.
Open regulatory controlTurn development evidence into a controlled ANDA packet.
BayesPK Generics makes regulatory submission work visible before the last mile: official sources, Module 3 evidence, eCTD planning, reviewer signoff, controlled correspondence, deficiency risk, and board-ready packet exports stay connected to the same program record.
FDA source watchPSG, Orange Book, labeling, guidances, and source snapshots with provenance.
Module 3 composerMap CMC sections to controlled evidence, owners, blockers, and next actions.
eCTD preflightBuild sequence plans, lifecycle operations, leaf metadata, and validation checks.
Deficiency responseSimulate likely agency questions and prepare response evidence.
Supplier riskScore API and excipient supplier qualification before launch gates.
Decision packet exportPackage readiness, risk, source movement, and decision history for leadership.
Interactive product tour
Inspect the decision workspace for each team.
Switch views to see how the same product evidence supports formulation, manufacturing, and regulatory decisions.
Balance similarity, performance, and cost.
Compare Q1/Q2 intent, excipient roles, dissolution behavior, process sensitivity, and tablet economics before locking the development formula.
Recommended module bundles
Open a complete workflow, not just a single tool.
Bundles group the modules that usually move together in a real generic program, so teams can move from question to evidence packet with fewer navigation decisions.
Understand the reference product and design space.
Reverse engineering, solid-state characterization, preformulation, formulation hub, QbD safe space.
Connect dissolution, IVIVC, and study interpretation.
Dissolution f2, biorelevant dissolution, IVIVC, BE dashboard, agency question simulator.
Move evidence into a reviewable ANDA packet.
Source watch, Program OS, Module 3 composer, deficiency response, eCTD preflight, decision packet export.
Protect product performance during manufacturing transfer.
Scale-up risk, pilot scale-up, BMR generator, QMS, stability tracker, cold-chain risk.
Connect filing windows to margin and supply decisions.
Patent tracker, pricing and margin, sourcing, regulatory calendar, post-approval change control.
Working modules
Open the workspace that answers today's question.
Search by decision or combine filters by operating layer. Each module links directly to a working BayesPK Generics workspace.
Stay in Generics while handing off adjacent questions cleanly.
Bayes Pharma.ai uses Generics for reference-to-ANDA decisions, Innovator for discovery and development strategy, and Clinical for patient-level reasoning. Route each team to the product that owns the question.
Bayes Pharma.ai Innovator
Innovator and discovery workflows for dose, translational, QSP, and development decision intelligence.
Open InnovatorBayes Pharma.ai Clinical
Clinical decision support for monitoring, diagnostic test suggestions, patient context, and benefit-risk review.
Open ClinicalKeep 505(b)(2) planning distinct from the ANDA operating record.
BridgeNDA supports internal pathway, evidence-reuse, and development-readiness planning when an ANDA may not fit. It does not autonomously classify, approve, sign, file, or communicate with an agency.
BridgeNDA controlled workflow
Run a program-scoped workflow only after identity, tenancy, runtime, and human-review controls are verified.
Open controlled workspacePathway planning boundary
Compare ANDA and 505(b)(2) considerations with unresolved evidence and qualified regulatory review kept visible.
Open pathway planner
Add BayesPK Generics to this device.
Keep the source-connected ANDA workspace available from your desktop or mobile launcher for frequent product development, evidence, and regulatory-control work.
Manual install instructions
- iPhone or iPad (Safari): tap
Share→ Add to Home Screen. - Android (Chrome): open the browser menu → Install app or Add to Home screen.
- Microsoft Edge: menu → Apps → install BayesPK Generics.
- Once installed, the app launches in its own window without browser chrome.
Start with one program
Turn a difficult generic product into a focused decision pilot.
Choose one molecule, formulation challenge, scale-up risk, or ANDA evidence gap. We will shape the walkthrough around a decision your team actually owns.
One product and one accountable decision
Labeled sample data before sensitive data
Clear success criteria and review boundary