Introduction
Development programs rarely stall on the science. They stall where one function hands off to the next. A board-ready roadmap puts every workstream on one timeline, so you can see the handoffs before they become delays.
The Four Phases
- IND-Enabling
- IND & Phase 1
- Phase 2
- Pivotal & Filing
The Eight Lanes
Clinical — Defines the trials the program must win.
Nonclinical — Builds the safety case each trial depends on.
CMC — Makes the right material, at the right scale, on time.
Regulatory — Sets the filing strategy every lane works toward.
Quality — Builds systems that scale from first GMP lot to approval.
Clinical Supply — Gets drug product to sites when patients are ready.
Medical Writing — Turns every lane’s work into one clear submission.
Governance — Keeps decisions, budget, and milestones aligned for the board.
Where Lanes Meet
01. Tox material = clinical material?
Lock the process before the tox batch, or plan the comparability bridge now.
IND-Enabling: Nonclinical + CMC
02. Phase-appropriate specs
Set specifications against the filing strategy, not after it.
IND-Enabling: CMC + Regulatory
03. First GMP lot
Quality systems and suppliers qualified before the campaign is booked.
IND & Phase 1: Quality + CMC
04. First patient, first vial
Plan drug product timing with the protocol, not after it.
Phase 2: Clinical + Clinical Supply
05. Every lane at the gate
Readiness judged across all eight lanes, not only the one that owns the deadline.
Pivotal & Filing: all eight lanes
Bottom Line
A roadmap your board can defend is one where every lane can see every other. When regulatory, CMC, quality, and nonclinical decisions are made together, gates stop being surprises.
How Syner-G Helps
- Integrated development strategy and roadmaps
- Scientific, Regulatory & Quality expertise in one team
- CDMO and CRO selection that follows the plan
Let’s Move from Science to Success. Let’s Talk
From science to success.
Get the full Integrated Development Roadmap Playbook — Download PDF
