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SATT PLATFORM

Telelink Business Services EAD

SATT PLATFORM

Telelink Business Services EAD

Serialization, aggregation and track & trace (“SATT”) platform for pharmaceutical companies

OVERVIEW

The SATT Platform is a comprehensive SaaS solution which offers end-to-end traceability and compliance to pharmaceutical companies while leveraging state-of-the-art cloud infrastructure design.

The SATT Platform enables the seamless integration of pharmaceutical serialization and aggregation into production processes, significantly reduces supply chain complexity, and ensures full compliance across both mature and emerging track and trace regulatory environments.

The SATT Platform is fully adapted to the needs of:

• Marketing authorization holders (“MAHs”)

• Single-site manufacturers (“SSM”)

• Multinational pharmaceutical organizations (“MPOs”)

• Parallel distributors (“PDs”)

• Contract manufacturing organizations (“CMOs”)

• Third-party logistics wholesalers (“3PLs”)

The solution offers:

• Easy generation of serial and aggregation numbers

• Seamless data exchange

• Efficient management of production processes

• Secure connection to various external partners (e.g., MAHs, CMOs, 3PLs, etc.)

• Bidirectional communication between internal production sites as well as with national and international authorities

• Generation of all relevant external and internal reports

KEY MODULES

Serialization data management

The SATT Platform provides efficient management of the serialization and aggregation production processes. It is an end-to-end solution for all factory production lines which generates automatic serialization and aggregation reports for the authorities.

Supply chain visibility

The SATT Platform provides full visibility of the supply chain, including coverage of marketing authorization holders, parallel distributors, contract manufacturing organizations and third-party logistics wholesalers, going all the way to the distribution of final products.

Regulatory compliance

The SATT Platform is an accredited software solution that meets the complete compliance requirements for a wide array of partners. The solution is being regularly updated to reflect ongoing regulatory changes and aggregates all compliance related information in a single place.

MAIN FEATURES

Serialization data management

• User-friendly interface with multi-language setup

• Multi-market compliance management capabilities

• Capacity for customization to any set of existing production processes

• Easy generation of highly customized reports in a variety of file formats

• Unlimited generation of serial & aggregation numbers

Supply chain visibility

• Automatic, semi-automatic or manual, fully secured data exchange with any external partners' systems

• Smart, customized internal and external reporting

• Complete adaptation of services to existing production processes

• Automatic connections to critical existing IT systems (e.g., EPR, WMS, etc.)

Regulatory Compliance

• Prompt reporting to EMVO, including support for all events and messages

• Capacity to establish a connection to any other regulatory system

• Stable and reliable connection with no downtimes through regulatory updates

• Product master data management

• Target markets management

• Wholesaler management

• Product pack data management

• Alert management

KEY BENEFITS

Economic & Reputational

• A drastic reduction in revenue loss associated with counterfeited pharmaceutical products

• Improved market reputation resulting from minimized incidents with fake drugs

• Reduction of operating costs resulting from enhanced process efficiency

Visibility & Compliance

• Improved transparency in front of internal and external stakeholders

• Prompt regulatory reporting to the authorities and deployment of regulatory updates through a stable connection with no downtimes

• Full compliance with EU FMD, US DSCSA, ANVISA & NMPA and no downtimes during regulatory updates

Technical & Operating

• Advanced serialization and aggregation data management

• Secure data exchange with external partners’ systems

• Seamless integration with existing internal systems

• State-of-the-art cloud infrastructure design allowing for high availability, maximum security and seamless scalability

• Highly qualified, Europe-based support team that offers lifetime, 24/7 technical assistance

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