In the process of acquiring the license for marketing authorisation of a medicinal product held by a third party, the acquiring company would need to sign among many a technology transfer agreement/protocol covering areas that are of special interest and importance. Among those are the legal status of the proposed medicinal product, its technical details and how they can be transferred to the new holder. In this aspect the following services can be provided:
- Carrying out Due Diligence/Gap Analysis with recommendation to ensure dossier completeness and up-to-date standard.
- Revision of the manufacturing process validation protocol to be undertaken by the acquiring company and compliance with the current regulatory and technical standards is assured.
- Reviewing the methods of analysis used to control the quality of the finished product during manufacture (IPC), release and stability and the protocol to be undertaken by the acquiring company to ensure their validity and compliance with current requirements.
- Reviewing the SmPC, PIL and labelling of the proposed medicinal product to ensure compliance with the current license and regulatory standard.