Technology Transfer

A technology transfer – whether pre- or post-approval, whether within a company or between independent enterprises – needs to be carefully planned and managed.

In addition to the technical details of a process and/or analytical procedure(s) to be transferred, the regulatory responsibilities of both parties involved (sending and receiving unit) need to be clearly defined and followed.

This includes identifying what regulatory submission documents will be required as a result of the transfer and who will be responsible for preparation and submission of those documents.

For a successful and efficient technology transfer, planning – including any regulatory
activities – should begin at a very early stage.

PhACT supports its clients with compiling the submission-ready documentation of a technology transfer.