Filing for health agencies

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 drug.

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 pre-clinical 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 stick with regulatory guidelines released these two last decades (see flowchart here below).

eCTD publishing

Our dedicated team ensures the technical quality of the submission package according to applicable eCTD specifications and requirements. 
 

Club Phase 1
GMP - Groupe de Métabolisme et Pharmacocinétique
EUFEMED
AFSSI