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Regulatory Service

MEDICAL DEVICE & IVD REGISTRATION

  • General medical device; IVD; medical devicedrug interphase
  • Device Classification
  • Technical File Preparation, CSDT
  • Technical Document Submission
  • Post-market surveillance

PHARMACEUTICAL & COSMETIC REGISTRATION

  • New Drug Products, biologics; generics, health supplements; natural products; medical device-drug interphase; OTC; cosmetic
  • Strategic Regulatory Consulting
  • Dossier management
  • Regulatory Submissions
  • Pharmacovigilance

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