our services

Regulatory Affairs Expertise

Tech Observerís Regulatory Affairs Professionals are dedicated to ensuring the successful and timely submission of your application. We work closely with you to provide strategic regulatory guidance to:

  • Expedite the compilation and submission of your application

  • Produce a submission acceptable to local global regulatory authorities

Service Partners

Our Services include:
  • Regulatory Consulting

  • Regulatory Operations

  • Electronic Submissions/eCTD

  • Regulatory Agency Liaison

  • Regulatory Due Diligence

  • Device Classification and Strategy

  • Critical Literature Review

  • Report preparation/publishing/submission

  • Regulatory Intelligence Center

  • Post-submission support (e.g., annual reports, amendments, variations)

Service Partners

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