Regulatory Services

Our aim is to ensure a smooth process and compliance with regulatory requirements for pharmaceutical products.

Regulations of different countries allow for the potential acquisition of special permits for certain medications classified as Vital and not Available. In such instances, our team of professionals extends support to companies, aiding in securing regulatory assurances. We provide the following services:

  • Scientific assistance in preparing dossiers for new biological drugs to be submitted before specialized committees.
  • Facilitation of requests for registration, modification, authorization, and certification of medication changes.
  • Organization of comprehensive technical and legal pharmacological dossiers for submission to the health agency.