Global Regulatory Compliance Software | Level 5

Global Regulatory Compliance Software | Level 5
Product Description

SATT PLATFORM ensures secure, compliant, and real-time integration with national regulatory systems for pharmaceutical serialization and traceability. Built on Microsoft Azure, the solution guarantees reliable performance, robust data protection, and adaptability to evolving global compliance requirements.


Key Features:

  • Seamless integration with multiple national hubs and platforms
  • Real-time data validation and reporting
  • Compliance with GS1 standards and certified by regulatory authorities
  • Automatic updates reflecting latest regulations
  • Audit-ready architecture with traceability logs

SoftGroup AD

  • Country/Region:
    Bulgaria
  • On CPHI since:
    2015
  • Certificates:
    3
  • Employees:
    50 - 99
Company types
IT/Software solution provider
Primary activities
Technology
Specifications
  • Details
    Specifications:
    • Real-time, automated data exchange with national traceability authorities
    • Secure communication over encrypted channels (Azure-based)
    • Support for multiple file formats (XML, EPCIS, etc.)
    • Continuous updates based on latest regulatory changes
    • Configurable reporting workflows




    Application Areas:
    • Marketing Authorization Holders (MAHs)
    • Pharmaceutical Manufacturers and CMOs
    • Wholesalers and 3PL Providers
    • Repackagers





    Operating in regulated markets such as: EMVO, Tatmeen, ASL Belgisi, IS MPT, ЦДМ, EBD, DVTIS, NHRA-MVC

  • Selling Points
    Selling Points:
    • Reduces manual effort and error risk
    • Maintains full compliance across diverse regulatory environments
    • Ensures uninterrupted communication during audits or system upgrades
    • Scalable for multi-market operations
    • Trusted by pharmaceutical companies in 30+ countries


  • Model
    Secure and Compliant Connection to National Systems

SoftGroup AD

  • Country/Region:
    Bulgaria
  • On CPHI since:
    2015
  • Certificates:
    3
  • Employees:
    50 - 99
Company types
IT/Software solution provider
Primary activities
Technology

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