Regulatory Support Services

Please connect with us for all the miscellaneous support required for submissions:


  • Dossier Due diligence
  • Medical writing- Co & NCO CTD Modules
  • Genotoxicity study by Software
  • Clinical activities :
    • Clinical and non clinical Overviews and summaries modules 2.4, 2.5, 2.6 and 2.7 report writing for EU And row submission.
    • Auditing and Monitoring the clinical studies from Phase –I to IV and Pilot and pivotal BE studies for sponsors or clients at the CRO.
    • Genotoxicity study for API and its impurities and components by softwares
  • Pharmacovigilence :
    • PSURs,
    • PSMF (DDPS),
    • RMP,
    • QPPV,
    • AE’s and SAE’s reporting,
    • ADR reporting.
  • Readability study or User testing of PILfor EU
  • Batch release/testing support for EU
  • Translations
  • Sourcing of RLD and reference standards

For bussiness Query and talk