Meeting FDA and EMA requirements with confidence
Pharmacometrics is now an integral part of regulatory submissions. We deliver high-quality PK/PD analyses and models, aligned with agency expectations, to support IND/CTA, NDA/BLA/MAA submissions, as well as key interactions with the FDA and EMA.
Why pharmacometrics matters
Over the past years, a large majority of new drugs approved by the FDA have benefited from significant pharmacometric contributions throughout their development programs. Modeling & Simulation is now an integral part of the submission package for new investigational drugs.
Regulatory-grade analyses, seamlessly integrated into your submission
PhinC delivers high-quality PK/PD analyses and models designed for regulatory use: full traceability, defensible assumptions, and reproducible workflows.
Predictive models
Transparent, well-controlled modules and structured deliverables to support clinical and regulatory decision-making.
Submission-ready reports and appendices
Clear narratives, defensible results, and technical appendices ready to be integrated into CTD/eCTD modules.
Support for agency interactions
Preparation of regulatory briefing materials for advice requests and question-and-answer cycles.
In-depth knowledge of regulatory authority expectations
Our pharmacometricians support preclinical and clinical programs (PK/PD, exposure–response, variability, covariates, DDI, special populations) with a strong focus on traceability and consistency. This experience ensures clear, defensible submission packages: explicit assumptions, justified choices, reproducible analyses, and actionable conclusions to support development strategy and interactions with regulatory agencies.
Deep regulatory culture
From the analysis plan to the report structure: key messages, full traceability, and alignment with guidelines and CTD/eCTD logic.
Reproducible workflows
Robust, fully version-controlled, and fully auditable analysis pipelines: from input data to final results, with no ‘black box’.
Clear and defensible rationale
Assumptions, limitations, sensitivity analyses, and interpretations documented to facilitate review and support robust decision-making.
Submission-ready report
Our dedicated team ensures the technical quality of the submission package in compatibility with applicable eCTD specifications and requirements, as well as health authority expectations.