A proven method to
monitor tech transfer

Galenicum has developed a proven method for monitoring the progress of tech transfer projects. It includes a weekly Flash report system with a list of identified activities, the progress made on each, and the actions to be taken should any issue arise.

This method has achieved extremely positive results, and our clients report that they derive great value from the transparency of the process.

The following process is typically used for projects of this type:

Programme Management

  • Manufacturing skills / capacity
  • Compliance with EU guidelines
  • GMP certified
  • Relevance of Galenicum to overall capacity
  • Timings
  • Economic feasibility
  • Technical feasibility
  • CDA signature
  • Sharing Manufacturing Guidelines
  • Timeline definition
  • Follow-up / local presence
  • Preparation of all variation documentation packs
  • Assistance in agency follow-up

On-going Supply

  • Planning.
  • Manufacturing.
  • Transport / Importation Management.
  • Storage and Delivery.
  • EU Batch Release.