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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).

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