Company Update: SK pharmteco to Expand Capabilities with Acquisition of Controlling Interest in CBM | Learn More
Logo yposkesi
waves image

Regulatory support and guidance

To help you successfully navigate the administrative process, Yposkesi’s regulatory unit:

  • Defines Yposkesi’s regulatory strategy according to its activities, the product manufactured, and their stage of development;
  • Oversees the regulatory management of the pharmaceutical establishment;
  • Provides legislative and regulatory watch to ensure compliance;
  • Provides regulatory intelligence and technical support to services and customers;
  • Coordinates and consolidates comments on draft and published regulatory texts and guidelines;
  • Establishes Yposkesi’s policy on ad-hoc questions;
  • Prepares CMC information as needed;
  • Supports customers in their response to health authorities for CMC information following IMPD filing;
  • Provides support for writing client IMPDs (to be established).

Would you like to know more ?

Contact us
Created by Yerokhoff Kostyiantine