ICSR processing

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Indivirtus (IHS) “Drug Safety Team” provides end-to-end case processing services during various phases of product development lifecycle; both in clinical as well as post-marketing drug safety surveillance starting from detection, assessment, and prevention of adverse events through ICSR management (case triage, data entry, quality check) of safety data to medical review and regulatory submissions through support of global electronic reporting systems {E2b (R2) OR E2b(R3)} compliant system.

Indivirtus Drug Safety Team comprises of experts in following domains:

  • Case Triage & Data Entry
  • Literature Review
  • Medical Review & Medical Writing
  • Global regulatory & Submission
  • Experienced Subject Matter
  • Global Safety Database - ARISg, Argus both E2b(R2) & E2(R3) compliant
  • Literature Database – Embase, PubMed etc
  • SOPs & Drug Safety System Writing
  • QA team to ensure 100 % compliance to quality standards
Our Clients:

Site Office

1st Floor, D-258, Industrial Area 8A SAS Nagar, Mohali Punjab 160055, India

Registered Office
5020 A, Sector 38 West Chandigarh 160014, India

Contact

director@indivirtus.com
ins_services@indivirtus.com
+91 172 4028586,
+91 9131925456,
+91 6280918142,
+91 8628808384