Optimize your development with a clear and traceable MIDD strategy.
Through integrated quantitative approach applied from the earliest stages of drug development, MIDD (Model-Informed Drug Development) enables the generation of robust predictive models to inform decision-making and guide development through Phase III.
Our experts support you from the earliest development stages through regulatory submission.
Evidence‑based decision‑making and a well-justified dose.
Informed strategic decisions
Anticipate outcomes and reduce risk at key stages of development.
Smarter clinical trials
Reduce the number of cohorts, optimize dosing regimens, and shorten timelines.
Strengthened regulatory dialogue
Support your decisions with transparent, model-based evidence.
MIDD is supported by regulatory agencies.
Regulatory agencies increasingly value MIDD Strategy to improve development efficiency, strengthen dose justification, and support robust decision-making.
🇺🇸 FDA Paired Meeting
FDA Paired Meetings enable early alignment of modeling strategies with the agency expectations, helping to secure key decisions and de-risking future submissions.
📘 ICH M15 – Guideline MIDD
The ICH M15 guideline formalizes the principles of Model-Informed Drug Development and recognizes its central role in development decision-making.
🇪🇺 EMA & mechanistic models
The EMA highlights the value of mechanistic models to strengthen assessment, interpretation, and the robustness of decisions within a MIDD framework.
A comprehensive MIDD strategy,
designed to guide your key decisions.
From hypothesis definition to final recommendation, we combine modeling, simulation, and regulatory expertise to deliver clear, actionable outputs directly usable by your non-clinical, clinical, and regulatory teams.
From lead optimization to filing
Speed up candidate and target profile selection. PhinC helps you prioritize options through a mechanistic modeling.
→ Discuss framingAnticipate translation to humans. PhinC helps you secure exposure, starting dose and key assumptions.
→ See PBPK / PKPDSecure first administration and escalation. PhinC helps you control PK, tolerance and cohort design.
→ Optimizing a FIHAccelerate patient proof-of-concept.
PhinC helps you optimize the dose-exposure-response relationship for dose selection.
→ CTS & PoCConfirm your dosing strategy. PhinC helps you anticipate variability and strengthen the robustness of your results.
→ De-risk my Phase III studyTurn your data into a regulatory argument. PhinC helps you justify dose and regimen with a clear, traceable narrative.
→ Regulatory SupportTailored approaches, adapted to every development challenge.
One objective, one deliverable: from a fast, targeted answer to a full mechanistic model. We tailor the level of complexity to the maturity of your data.
PBPK - PBBM
Extrapolate across species, routes, and populations when data are limited.
QSP
Make fast, consistent, data-driven decisions aligned with clinical objectives.
PopPK / PK-PD
Understand systemic exposure and quantify variability to guide dosing.
QT/QTc Analysis
Provides robust, critical predictions to assess the risk of QTc prolongation.
PK NCA CDISC
Ensures robust, fully compliant analyses for regulatory submission.
CTS
Structures the clinical strategy and secures key development decisions.
Predictive models to de-risk drug exposure-response
Concrete recommendations and justification models.
Dose recommendations
Proposed dose(s) and regimen, with defined confidence levels and safety margins.
Scenarios simulation
Test trial scenarios to optimize doses, sample sizes, and endpoints.
Regulatory Support
Support development decisions in discussions with health authorities.
Let's build your MIDD roadmap
Share your development stage, available data, and next target.
We will propose a clear strategy, timeline, and deliverables.
- Objective & expected decisions
- Mandatory data (minimum viable)
- Delivrables & timelines
- Support for regulatory submission