A month-by-month plan from candidate selection to IND clearance, computed from the real dependencies: material gates toxicology, validated methods gate the GLP studies, and the last tox report gates submission. Pick your modality, adjust any duration, and watch the critical path move. Then chase quotes for the critical-path work first, because that is where a slipped slot costs you a month for a month.
Durations start at published typical values. Edit any of them below and the plan reflows from the dependencies: material gates toxicology, validated bioanalytical methods gate the GLP studies, and the last tox report gates the IND. The highlighted bars are the critical path: slip one of those and the IND date moves with it.
| Task | Duration (months) | Window | Source it |
|---|---|---|---|
Route work + non-GMP API for tox critical path High-dose non-rodent studies can consume kilograms; size the campaign from the dose math. | typical 2-6 | M1 to M4 | Compare quotes |
Dose range finding (rodent + non-rodent, non-GLP) Sets the doses the seven-figure GLP studies will run at. | typical 2-4 | M5 to M7 | Compare quotes |
Genotoxicity battery Waived for most biologics under ICH S6(R1); ADC payloads still need it. | typical 2-4 | M5 to M7 | Compare quotes |
Bioanalytical method development + GLP validation critical path Validated methods must be ready before pivotal TK samples flow; the classic silent gater. Method work starts on reference material, so it does not wait for the tox lot. | typical 3-6 | M5 to M8 | Compare quotes |
GMP batch + drug product for Phase 1 Runs in parallel with the pivotal tox package; slot lead times decide the real start. | typical 4-8 | M5 to M9 | Compare quotes |
Safety pharmacology core battery Runs in parallel with the pivotal tox studies; telemetry slots are the constraint. | typical 2-5 | M8 to M10 | Compare quotes |
Pre-IND meeting (prep, briefing book, meeting) Cheap insurance: FDA agreement on the tox package before the expensive studies finish. | typical 2-4 | M8 to M10 | Compare quotes |
28-day GLP repeat-dose tox, 2 species (in-life + draft report) critical path In-life is a month; the audited report is most of the wait. Slot booking adds real calendar time. | typical 4-7 | M9 to M13 | Compare quotes |
Stability initiation on GMP lot The IND needs stability data underway, not complete. | typical 1-3 | M10 to M11 | Compare quotes |
IND authoring, publishing, submission critical path Module writing starts earlier in practice; the last draft tox report gates submission. | typical 2-4 | M14 to M16 | Compare quotes |
FDA 30-day review critical path The clock the whole plan runs toward. Clinical hold questions land here if the package has gaps. | typical 1-1 | M17 to M17 | Compare quotes |
Durations are published typical ranges for 2026 and every dependency is a real program gate, but calendars are made of CRO slot availability: the same plan can move months on booking alone. Budget the plan with the IND Budget Calculator, then get slot dates and real quotes from suppliers on the critical path first.
Common questions
How long do IND-enabling studies take?
Published typical timelines run 12 to 18 months from candidate selection for a small molecule and 15 to 24 months for a biologic, ending with the FDA's 30-day review. The spread is mostly CMC: a biologic spends its first year on cell line and process development before pivotal tox can even start. The planner's defaults sit near the top of those bands, and the biologic default runs slightly past 24 months, because it assumes no overlap at all between cell line development, process development, and dose range finding. Programs that overlap those steps land inside the published range.
What actually gates the IND date?
Four dependencies do most of the gating: tox-usable material gates dose range finding, validated bioanalytical methods gate the GLP studies, the draft GLP tox report gates IND submission, and the FDA's 30-day clock ends the plan. The planner highlights whichever chain is longest for your inputs.
Why does the biologic timeline start so much earlier on CMC?
Because nothing toxicology-related can start until there is representative material, and for a biologic that means cell line development plus process development first. That chain is typically 10 to 16 months on its own, which is why biologics reach IND later than small molecules on otherwise similar programs.
Can these timelines be compressed?
Some overlap is normal: safety pharmacology runs alongside pivotal tox, IND writing starts before final reports, and pre-IND feedback lands mid-program. The compressions that go wrong are skipping dose range finding and starting GLP studies before methods validate. CRO slot availability is the other lever: booking early buys more time than optimistic Gantt bars.
Is this a promise of my timeline?
No. It is a planning skeleton built from published typical durations and real dependency logic. Your dates will move with study design, slot availability, and findings along the way. Use it to see which quotes to chase first, then get real slot dates from suppliers.
Plan the money next to the months
The same program priced line by line lives in the IND Budget Calculator, and the full cost context is in what it costs to reach IND and GLP toxicology study costs. When the plan holds up, compare quotes from vetted suppliers, starting with the critical path.