More than 90% of all novel drugs approved by the US FDA over the past few years have leveraged pharmacometrics in their development program. M&S is now a significant part of the regulatory submission file of new investigational drugs.
PhinC Development provides high-quality, regulatory-compliant PK/PD analyses and modeling for regulatory submission packages.
In-depth knowledge of regulatory guidance and requirements
Our pharmacometricians supported many preclinical and clinical study analysis and modeling for new investigational drugs, they have consequently developed significant experience in delivering reports intended for submission.
This experience is based both on frequent and regular exchanges with health agencies and an in-depth knowledge of regulatory guidance and requirements:
- by way of indication, PhinC Development is involved every year in approximately 10 seek for advice (FDA/EMA), 20 study protocols, 40 reports intended for submission,
- PhinC Development processes, practices and tools have been set up progressively in order to meet the regulatory guidelines released these two last decades (see flowchart here below).
Our dedicated team ensures the technical quality of the submission package according to applicable eCTD specifications and requirements.