Packages

Packages

One development decision per package, ending with the document you file. Fixed price, paid at milestones.

If the question is not clear yet

MIDD Strategy Sprint

Five days, at a fixed fee credited toward the work that follows: the questions of interest across your program, a draft M15 assessment for each, and a regulatory interaction plan.

Fee
Fixed, quoted on the call
Book a sprint
First-in-humanSet a first-in-human dose you can defendTranslational PK/PD Phase 1Make the QT case from Phase 1 dataConcentration-QTc · ICH E14/S7B Phase 1–2Decide which DDI studies you still needPBPK · ICH M12 End of Phase 2Choose and defend the Phase 3 doseExposure-response · Project Optimus PediatricsDose children with less pediatric dataPopPK with maturation · ICH E11A Life cycleChange formulation or route without losing exposurePopulation PK bridging FilingMake the dossier's MIDD evidence review-readyNDA · BLA · MAA GenericsSize the BE study before you run itBE study design · ICH M13A Any stageFind out if an inherited model will hold upModel takeover and audit

Also on request: NCA and TFLs, organ impairment and ethnic bridging, translational PK/PD, due diligence for licensing, and a fractional pharmacometrics department.

What every package includes

Structured following ICH M15.

Before modeling starts

Model analysis plan

Question of interest, context of use, methods and acceptance criteria. Your approval is the first milestone.

At delivery

Report and assessment

The model analysis report, the completed M15 assessment table and the verification package.

Always

Everything, handed over

Code, datasets, model files and run logs. You own all of it.

Not sure which package fits?

Tell us about the program. In a 15-minute call we point you to the right package, or to the MIDD Strategy Sprint if the question is not clear yet.

Discuss your program