Regulatory Consulting

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Regulatory Consulting

We help companies to obtain various market regulatory approvals (end to end) to distribute their devices legally around the globe.

  • CDSCO India
  • USFDA approvals (510k, IDE, Denovo, PMA)
  • CE Certification (EU MDR & EU IVDR)
  • TGA Australia
  • Health Canada
  • UKCA
  • SFDA
  • MDA Registration
  • HSA Registration
  • COFEPRIS Registration
  • Brazil ANVISA