Medical Device Regulatory Services in Japan

Freyr, as a strategic Regulatory partner, provides end-to-end Medical Device Regulatory services that span across quality control, classification, clinical safety and market access. We assist clients in all the procedural challenges right from Regulatory intelligence to dossier preparation and submission to product registration.

Check out more at: Medical Device Regulatory Services in Japan

Freyr Expertise

Quality

  • Quality Management System (QMS)
  • Good Quality Practice (GQP)
  • QMS application to PMDA
  • Preparation for PMDA inspection
  • Local product release
  • SOP writing
  • Quality manual writing
  • FMA application
  • Due diligence audits

Clinical

  • CRO oversight and management
  • Product development
  • In-country Caretaker (ICC) for clinical trials in Japan
  • Clinical trial notification (CTN)

Safety

  • Receipt, review and coding of adverse events
  • Safety Reports to PMDA
  • Good Vigilance Practice (GVP)
  • Post-marketing Surveillance (PMS) studies

Market access

  • Market-access, pricing, reimbursement strategies
  • Due-diligence and asset evaluation
  • Evidence-based portfolio prioritization
  • Review of Target Product Profile (TPP) and label claims
  • Evidence and economic needs assessment and evaluation
  • Distributor selection
  • Commercial and marketing strategies

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