Regulatory Support
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).