Outsourcing has many advantages, such as. B the improvement of processes and standards throughout the industry through the worldwide dissemination of knowledge and technology. However, if the supply chain becomes too complex, monitoring of MAH processes can be significantly reduced. In our initial discussions with new corporate customers, we often find that complex multi-layered supply chains can confuse problems and that this understanding of the MAH or Contract Manufacturing Organisation (CMO) can become unclear. Regulatory professionals would generally view the Type I variant as a fairly simple regulatory procedure. New figures released by the EMA suggest something else.
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