PvEdge – Gateway Connect
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PvEdge – Gateway Connect

“Global ICSR submissions” is one of the integral aspects and most critical activity of every PV operations whether is MAH or PV service provider. A dedicated submissions team is assigned for this critical task of regulatory & partner ICSR submission.

Many cumbersome and time-consuming steps are involved in the manual submissions of ICSRs globally like in EMA, USFDA, Health Canada & UK MHRA submissions. Manual submission is also having a huge impact on the quality & accuracy of ICSR submissions which will result in multiple types of regulatory deviations like missing the regulatory timelines etc.

Just imagine!! If we don’t need to do all these manual efforts and time-consuming manual submission activities, then how much amount of time & resources we will be able to save behind each case i.e. approximately around 40-50 mins per case.

For the same purpose…

We at Sarjen Systems’, India had successfully established the ICSR submission via “Gateway” which we call it as “PvEdge-Gateway connect service” via which any PV operations/MAH can successfully submit their ICSRs globally to various regulatory authorities like US FDA, EMA, Health Canada, UK MHRA & Swiss Medic & License partners in fully automated manner.

The exclusive benefits are...

  • No manual intervention is required in ICSR submissions to regulatory authorities & partners
  • Fully automated ICSR submissions
  • Will be able to save around 70-80% of resources in submission team (Both Human & Financial)
  • Dedicated set up for each MAH/Client
  • Dedicated License Partner submission set up
  • Client can add multiple regulatory authorities on a single set up
  • Very much cost effective, which is best in industry
  • All the regulatory authority configurations and gateway registrations will be done by us, hence no functional burden on client
  • A complete service, support package which includes gateway monitoring and maintenance
  • Can be integrated with any safety database
  • Enhanced productivity and quality of the team
  • Enhanced regulatory submission compliance due gateway submissions as regulatory authorities always recommend gateway over manual submissions