Modality-specific program timelines, 11 universal stage gates with detailed Go/No-Go criteria, and program plans cross-mapped to CTD sections — so every deliverable has an owner, a phase, and a regulatory basis.
The Value of Early CMC Planning
Industry programs average 10–15 years from discovery to approval. The timelines below are aggressive but achievable — for programs where CMC requirements are understood early, deliverables are planned by phase, and gate decisions are made on evidence.
The gap closes when CMC is treated as a strategic discipline from Day 1 — not a filing exercise at the end. Every gate in this framework exists to confirm readiness before commitment, prevent late-phase surprises, and keep programs on the critical path.
Target identification, validation, lead discovery, and lead optimization. G0 through G4 gates. Development candidate nomination triggers pre-clinical phase.
Pre-formulation, formulation development, PK/PD, definitive GLP toxicology, GMP Drug Substance and Drug Product manufacturing, IND preparation and submission.
Clinical start-up, Phase I SAD/MAD, Phase II dose finding and EOP2, Phase III pivotal with concurrent PPQ manufacturing and CMC update submissions.
Disease rationale, cell therapy strategy, regulatory classification gate, construct selection, and process concept design. Shorter than SM due to targeted starting biology.
Cell collection and donor eligibility, cell processing and engineering, analytical method development, pre-clinical pharmacology and toxicology, CDMO selection, GMP manufacturing, and IND preparation.
Cell therapy typically combines Phase I/II into a single study. Pivotal concurrent with commercial process validation. BLA preparation overlaps Phase 3.
Target and disease biology, therapeutic strategy gate, modality decision gate (viral vector vs. oligonucleotide), lead vector construct selection, and pre-clinical pharmacology and biodistribution.
Production system development, GLP toxicology (long pole — biodistribution, genotoxicity), CDMO selection, and GMP viral vector manufacturing. Longest phase due to unique gene therapy vector biology.
Benefits from RMAT/PRIME designation and rare disease populations with smaller, faster-enrolling trial designs. Pivotal concurrent with commercial process validation. Long-term follow-up (LTFU) per FDA guidance.
Stage Gate Framework
Every gate follows the same governance structure: internal SME readiness assessment with scored criteria, gate review meeting, documented decision with follow-on actions, and formal cross-functional sign-off. Click any gate to see the full objective, criteria, and required signatories.
What's in the Detailed Program Plan
The program plan request delivers a modality-specific stage-gate schedule and gate checklist. The full program plan includes task-level cross-mapping, functional ownership, critical path analysis, and a Power BI-ready gate tracker — everything needed to govern a drug development program from Day 1.
Every task is mapped to the CTD/eCTD section it produces. See which tasks feed 3.2.S, 3.2.P, Module 4 (Nonclinical), or Module 5 (Clinical) — and which are IND vs. NDA deliverables.
Each task has an assigned functional owner — CMC, QA/REG, TOX, QC, CLIN OPS, MSAT, MFG, SUPPLY CHAIN, PM, R&D, and more. Ready to load into your project governance system.
The gate checklist workbook includes a PowerBI_GateTracker tab — a flat table with one row per gate criterion, ready to connect directly to your Power BI dataset for live gate readiness dashboards.
Every task includes Total Slack (days) and an On Critical Path flag. Long-pole tasks are pre-identified — carcinogenicity studies, pivotal enrollment, stability programs — so teams know where schedule risk lives.
21 gate checklists for Small Molecule (686 total criteria), 15 for Cell Therapy (492 criteria), and 15 for Gene Therapy (489 criteria) — each mapped to regulatory source and CTD section.
Every task includes a Definition of Done — the specific, verifiable output or condition that constitutes completion. Eliminates ambiguity at gate reviews and provides the basis for quality audit trails.
Submit your program information and receive the stage-gate schedule and gate checklist for your modality. Detailed task-level durations and costs are available through engagement.
Start With the Right Foundation
The CMC Navigator gives you phase-graded requirements for all 77 CTD Module 3 sections. The program plan gives you the schedule, gates, and cross-mapping. Together they replace reactive CMC discovery with structured, aggressive-but-achievable execution.