Pharmaceutical serialization MAH
Serialization with SecIdent Pharma at MAHs
SecIdent Pharma helps contract manufacturing organizations (CMOs) make production more efficient and flexible. It also gives marketing authorization holders (MAHs) the central control and legal protection essential for market access. We bridge the gap between contract manufacturers and regulatory requirements, ensuring that your products reach the market safely and in compliance with the law.
Challenges for MAHs:
Complex connection: The technical hurdles and susceptibility to errors involved in manually connecting to the EU hub (EMVS) are high.
Documentation burden: The concern about presenting incomplete validation documents during inspections ties up enormous resources.
Heterogeneous partner landscape: Every CMO uses different systems. Data exchange often consists of different formats.
Here are the key pillars we use to support manufacturers with serialization:
Seamless EU Hub Connection: With BrainGate, we provide a fully integrated connection to the EMVS European Hub.
Compliance: With every SecIdent Pharma release, you receive complete validation documentation to ensure audit readiness.
Centralized control of your partners: Our workflows allow for easy exchange of data with partners, regardless of the systems they use. You can release individual batches on a targeted basis. All serialization data is stored centrally in SecIdent, so you always have 100% sovereignty over your product data.
