Rapid Setup of E-Submission Gateways for Regulatory Safety Reporting

Pharma Sponsors and Marketing Authorization Holders have the important responsibility of complying with global regulatory requirements by timely submitting all reported adverse events within the mandated timeframe to account for safety profile and the risk-benefit ratio of medicinal products. This requires companies to establish validated electronic submission gateways that facilitates transmission of IND Safety Reports, ICSRs, etc. directly from the safety database to different regulatory bodies in the E2B R2/R3 XML format.

At Techsol, we specialize in setting up Oracle Argus Interchange, an electronic submission and exchange module that enables the transmission of required ICH:E2B reporting functionality as well as the exchange of vital drug safety information with regulators and partners worldwide. Cases are reported instantly and accurately using standardized, worldwide reporting and transmission processes.

Our Safety Gateway Management Capabilities

Regulatory Submissions & Applications | Techsol Life Sciences

Services We Offer

Our safety technical team has the expertise to setup electronic gateways from the Oracle Argus Safety Database to:

  • United States: FDA’s Adverse Event Reporting System (FAERS) and the Individual Case Safety Report (ICSR) Portal
  • European Union: European Medicines Agency’s Eudravigilance Medicinal Product Dictionary (EVMPD) and Electronic Reporting of Suspected Adverse Reactions (E2B) Gateway
  • Japan: Pharmaceuticals and Medical Devices Agency’s (PMDA) ICSR Information Management System (IMS)
  • Canada: Health Canada’s Electronic Adverse Reaction Reporting System (EARRS)
  • Australia: Therapeutic Goods Administration’s (TGA) Adverse Drug Reactions System (ADRS)
  • Switzerland: Swissmedic B2B gateway
Activities We Perform

>   E-Submission Gateway implementation, configuration, and validation 

>   Configure Argus Interchange Service by updating the initialization (INI) file 

>   Validate generation of E2B XML files to ensure error-free XML submissions

>   Complete Report Generation Validations

>   Pilot testing completion with supporting documentation 

>   Troubleshooting failures and resolving reported incidents of gateways failures 

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