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Top 5 Indian MNC

  • ICSR Processing using Argus database v 6.0.7
  • Handling case volume of approximately 18000 to 20000 cases annually in all work flows (Triage, book‐in, data entry, peer review, medical Review, follow‐up and closure)
  • Current Signal detection activity on invalid literature for 105 molecules. Completed for 95 molecules in Q2
  • Literature review of citations and full‐text articles
  • SDEA preparation and review
  • 5 ad‐hoc projects – all delivered
  • Database migration activity to Argus– completed

Top 50 Indian MNC:

  • Case processing of live expeditable and periodic cases (including medical review) on Argus v 7.0.4 database – approximately 30000/year
  • Literature Review for 335 molecules on two major databases
  • Signal Management activity for 250 molecules including labeling updates
  • Authoring of 100 package inserts
  • Authoring of 100 PSURs/annum for regional submission
  • RMPs for licensed products for international submission
  • Processed 7000 backlog Individual Case Safety Reports using client’s AERS Database.

Top 50 Indian MNC:

  • Signal Management activity from literature screening and review for 8 molecules (including bio-similars)
  • Literature screening and review for authoring of PSURs for 6 molecules (including bio-similars)
  • Authoring of safety documents – RMPs and PSURs (written 30 so far)
  • Individual Case Safety Reports processing from literature sources using Argus database

Ukranian MNC:

  • Set up of the PV system in collaboration with Dr Regenold GmbH in Germany
  • Literature screening for ICSRs for seven generic products on PubMed
  • End to end case processing on Argus database
  • Quarterly Signal Detection activity and Safety Review Meetings for seven products
  • Risk Management Planning activities in collaboration with the EUQPPV

Indian company (now acquired by Top 5 generic players in the world)

  • Processed 3500 Individual Case Safety Reports in 2 months using client’s AERS Database
  • Conducted Signal Management activity for 201 molecules including labeling updates

German MAH

  • Risk Management Plan for a hybrid generic for BfARM, Germany submission

German MAH

  • One PSUR for Russia submission.
  • Two PBRERs for Germany submission

German MAH

  • One RMP for German submission

Switzerland MAH

  • One RMP for Switzerland submission
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