Conseil pharmaceutique

ABOUT US

DextReg is a regulatory affairs consultancy in the pharmaceutical and health products area.

Created in 2007 with the aim of becoming a recognized reference in the regulatory area, DextReg specializes in strategic regulatory consulting, quality assurance, technical assistance and the preparation of registration dossiers for all types of health products.

Quality Assurance support activity for an Exploitant site

DextReg also provides an Exploitant Quality Assurance support to all pharmaceutical companies in order to meet regulatory requirements.

SUPPORT

  • Creation and implementation of an Exploitant site in France: Setting up the pharmaceutical quality system for a new Exploitant site in order to obtain the opening license and preparing the corresponding SOPs / Line extensions.
  • In the deployment of new Activities : Charter and the referential of the promotional information, management of psychotropic drugs and / or narcotics,implementation of process and creation, revision of the documentary system

TRAININGS

We also offer intra-company regulatory affairs trainings on the following topics :

  • Pharmaceutical variations
  • Industrial Regulatory Affairs

regulanet

DextReg is a member of the Regulanet network since 2007 :

A network of regulatory affairs consultants with members in 90 countries around the world.