Improving Compliance and Reducing Transport Risk



Control and Reduce Supply Chain Risks

For many countries, the pharmaceutical industry is one of the most significant sectors, with its products contributing to people’s quality of life and life-expectancy. However, the increasing globalization of production and distribution, and constantly changing conditions pose major challenges to the contributing parties within the supply chain – from production all the way to the consumer.

The legal situation has become stricter over the past years: In 2013, the European Commission published the Good Distribution Practice (GDP) guidelines, clearly allocating the responsibility for the quality of the pharmaceutical products to the pharma producer – from production along the entire supply chain and right up to the end patient. The guidelines also demand quality risk management from the pharmaceutical companies, with the goal of achieving better safety and transparency along the supply chain. They determine that the planning of transportation of pharmaceutical products must consider potential risks in order to avoid them wherever possible. As a consequence, manufacturers, wholesalers and logistics service providers want to make use of an intelligent IT system that comprehensively visualizes the transport chain in consideration of the possible risks.

Thus, there is a need in the market for a standardized, integrated, preventive supply chain risk management system!

Key Features

MYTIGATE is a risk management platform created by and for the pharma industry with a validated development according to FDA Guidelines (CFR21 Part 11).

We aim to fulfil the market need for a standardized, integrated, preventive supply chain risk management system by:

    • Providing risk metrics to pharmaceutical producers, wholesalers, forwarders and carriers based on the capabilities and performance of potential supply chain partners on a specific lane

    • Providing a standardized risk analysis and suggestions for risk mitigation measures

    • Evaluating which lane and which transport partner will be suitable for a particular product

    • Verifying new lanes with regard to regulatory compliance (e.g. EU GDP, FDA, IATA)

    • Presenting the proper documentation for regulatory authorities

    • Being a validated development according to FDA Guidelines (CFR21 Part 11)



Benefits for Pharmaceutical Producers, Wholesalers and Forwarders:

MYTIGATE will provide pharmaceutical producers, wholesalers and forwarders with a list of potential supply chain partners and their capabilities along a specific lane. Based on this information, the shipper and/or forwarder will be able to select specific lanes and service providers. Furthermore, the shipper and/or forwarder will be able to use MYTIGATE with all its knowledge on theoretical and real risks – based on temperature logger data – to select new routes. In addition, the information can also be used for certification and documentation to authorities.

Shippers will be able to significantly improve the quality of transports and reduce the number of GDP issues. This will enable pharma producers to reduce the costs for root cause analysis per transport, costs caused by scrapping cases, insurance costs as well as costs for packaging, active solutions or expensive transport modes.

Benefits for Transport Companies and Supply Chain Partners

MYTIGATE will offer a platform to present the supply chain partners’ services with a focus on capabilities and certificates. Finally, quality will become visible and transparent. They will be able to showcase their different infrastructural capabilities and certificates and be objectively benchmarked against other competitors through MYTIGATE as a one standardized database.


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