BA/BE & Dossier Development
In-house BA/BE + development dossier under one roof means a first-time filing lands roughly four months sooner. Below is where that number comes from, and what it's worth on your molecule.
Prefer to talk it through? Book a call →If the pilot BE fails (industry-typical 20–30% for topicals, MR and high-variability drugs), the outsourced route restarts steps 1–2 (≈10–14 more weeks of re-contracting and re-queueing). In-house, it's a re-slot. That's why the saving used below is a P50 of ~4 months, not a ceiling: state it as a range, not a guarantee.
Five inputs drive it. Everything else (erosion curves, repeat-study risk, discount rate) is a defaults set you can open and edit.
Dollar figures throughout (this slider, and the CRO/in-house cost defaults under Advanced assumptions) are calibrated for USD-scale amounts. Adjust them manually after switching currency.
Starting margin. It erodes year over year across the product's remaining lifecycle, see Advanced assumptions.
P50 default is 4; use 6–7 to reflect the repeat-study protection scenario.
As competitors enter and prices erode, margin typically falls 3 to 5% a year. Compounds across the lifecycle above.
Denominator for the ROI multiple. Defaults to the in-house BA/BE + dossier cost.
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Up to ~4 months on a typical first-time filing, based on the 5-step bridge above. V2 is usually the number that lands hardest. It isn't extra speed, it's a permanent shift in who you are on the shelf.
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