API Technology Transfer

 

Our SOP's, Batch Records and Technical Work Instructions are in place to ensure the traceability of the relevant development and manufacturing data. If needed, the development data can be exported in an eCTD format for incorporation into your registration dossier.

 

As a client you have direct access and gain insight in the development and production development progress, by web-based availability of the relevant development reports, QC and status reports.

 

Besides the transfer of the complete documentation, training of local production staff at our location is included in the project. Moreover, our staff will be present at the client production site to train the staff on site and monitor the first production batches.

Post transfer assistance will be carried out so that possible questions or technical issues can be dealt with quickly.