Global Product Registration Services

Global Product Registration Services

We provide end-to-end support to MedTech companies for preparation and submission of regulatory applications including Conformité Européene (CE) Technical Files, 510(k) submissions, Premarket Approval (PMA) applications, Health Canada Medical Device License (MDL) applications and other regulatory filings for global markets.

Key Offerings

  • Pre-submission preparation and meeting support
  • Health Authority recommendations implementation plan
  • 510(k) and Premarket Approval (PMA) submissions​
  • Conformité Européene (CE) technical file preparation​
  • Other global market regulatory submissions​

Key Benefits

  • Extensive experience with global regulatory landscape​
  • All-encompassing services for pre-sub packages including review of technical documents
  • End-to-end support to compile all the necessary information for submission
  • In-depth evaluation of Health Authority recommendations and detailed implementation plan​
  • Expert assistance with query response and interaction with the agencies until final approval​