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Our Services

Yposkesi is a full-service CDMO, providing professional support through all stages of gene therapy development. We make available the entire viral vector manufacturing services necessary to enable you to rapidly and successfully develop ATMPs. You gain access to specialized expertise with integrated project management as well as streamlined and cost-efficient bioprocess development services:

Regulatory support

In helping you successfully navigate the administrative process, Yposkesi’s regulatory unit:

  • Defines Yposkesi’s regulatory strategy according to its activities, the products manufactured and their stage of development
  • Oversees the regulatory management of the pharmaceutical establishment
  • Provides legislative and regulatory watch
  • Provides regulatory Intelligence / Technical Support to Services and Customers
  • Coordinates and consolidates comments on draft/for comments regulatory texts, guidelines, …
  • Establishes Yposkesi’s policy on adhoc 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 (not yet available)

Our platform