Generics regulatory command center

Move from PSG signal to reviewable ANDA control.

BayesPK Generics gives regulatory, CMC, BE, QA, legal, and portfolio teams one lane for source posture, evidence readiness, Module 3 control, eCTD preflight, correspondence triage, patent timing, and lifecycle handoffs.

Open Submission Workspace Open ANDA Board Open Program OS Run Control Tower
PSG and source posture eCTD and Module 3 QC Controlled correspondence triage Source-connected v4 control
Operating model

Make every regulatory risk visible before packet lock.

Generics regulatory work is strongest when PSG, RLD, BE, dissolution, quality, Module 3, patent timing, and post-approval commitments move as one controlled evidence system.

Source posture

Track PSG, ANDA requirements, eCTD standards, Orange Book, labeling, and correspondence guidance before relying on a packet.

Run source watch

Source-connected v4

Run FDA source snapshots, master-data control, evidence graph, eCTD sequence workbench, risk v2, correspondence packet, and calendar autopilot as one command.

Run v4 control

Evidence control

Carry controlled evidence from Program OS into readiness scoring, reviewer signoff, vault export, and board packs.

Open Program OS

Module 3 command

Keep Q1/Q2, QTPP/CQA, dissolution, methods, manufacturing, controls, stability, and commitments mapped to CTD sections.

Compose Module 3

Decision packet

Export board and regulatory summaries from source posture, CMC evidence, deficiency risk, supplier posture, and launch readiness.

Build packet

eCTD QC

Build a leaf plan, lifecycle operations, validation checklist, manifest, and publishing boundary before final eCTD work.

Open submission

BE and performance

Connect BE design, PSG alignment, dissolution profiles, IVIVC context, and biorelevant evidence into deficiency-risk analysis.

Open BE

Correspondence triage

Separate internal gap closure, controlled correspondence, and pre-ANDA escalation using specific source-backed questions.

Run triage

Patent and launch

Reconcile RLD basis, patent certifications, exclusivity, Paragraph IV posture, filing timing, and market launch assumptions.

Open patent

Lifecycle calendar

Track filing date, correspondence clocks, review commitments, annual reports, supplements, and post-approval changes.

Open calendar
ANDA evidence spine

Run regulatory from source to controlled handoff.

This is the generics version of a gold-standard regulatory lane: product-specific evidence first, then controlled authoring, then package QC.

Product source basis

RLD, PSG, Orange Book, labeling, dosage form, strength, route, and market strategy.

Development evidence

QTPP/CQA, Q1/Q2, RLD reverse engineering, formulation rationale, and method strategy.

Performance proof

Dissolution, biorelevant media, BE study plan, PK/statistics, and residual performance risk.

CMC packet

Drug substance, drug product, manufacturing, controls, validation, stability, and commitments.

eCTD preflight

Module map, leaf manifest, lifecycle operations, source links, and validation checks.

Agency readiness

Deficiency risk, question simulator, correspondence package, reviewer workflow, and calendar handoff.

Control tower · quick check

Run the ANDA regulatory operating check.

A lightweight snapshot of source posture, readiness, deficiency risk, eCTD QC, and correspondence triage -- for the full authoring workspace (evidence graph, Module 3 matrix, eCTD sequence builder, controlled report packages), open Regulatory Submission Workspace instead.

Regulatory tower output will appear here after the backend check runs.
Submission boundary

Serious regulatory products need clear boundaries.

BayesPK supports evidence preparation and review control. Sponsor teams still own strategy, validation, legal certifications, final publishing, and submission authority.

Supported

  • PSG/source posture
  • ANDA evidence readiness
  • Module 3 mapping
  • eCTD preflight planning
  • Correspondence triage
  • Reviewer workflow and packet exports

Requires sponsor control

  • Final regulatory strategy
  • Qualified CMC, BE, QA, legal and regulatory signoff
  • Validated eCTD publishing
  • Formal gateway submission
  • SOP and quality-system alignment

Not positioned as

  • FDA acceptance guarantee
  • Certified publishing engine
  • Direct agency gateway
  • Replacement for regulatory judgment
  • Replacement for GMP documentation
Submission workflow

Use the command center as the regulatory front door.

Start with source posture, move into Program OS for controlled evidence, then assemble the submission workspace and calendar handoff.

Open Program OSOpen Submission