• WHAT WE DO

    WHAT WE DO

Regulatory

All Technologies i.e. Biomedical Devices & Diagnostics, Pharmaceutical and Biopharmaceutical Drug Products

  • Develop regulatory product approval strategies by geographical region
  • Pre-submission consultations and meetings with regulatory agencies (e.g. US and China FDA’s, Notified Bodies, Australian TGA, New Zealand's MedSafe)
  • Interact and negotiate with regulatory agencies
  • Import and export consultation for global product development
  • US and China FDA submissions
  • Product filings and liaison with other Asian markets including Japan and ASEAN
  • Management and review of regulatory filings
  • Due diligence to assess regulatory compliance
  • Audits

Biomedical Devices & Diagnostics

  • Evaluation of notified bodies (NB)
  • Preparation for NB audits
  • Preparation of technical dossiers
  • Provide regulatory guidances including FDA, NB-MED and MEDDEV
  • CE marking
  • US Filing (Invesitgational Device Exemption applications (IDEs), 510(k), and Premarket Approval applications (PMAs))
  • Labeling updates
  • Design changes and enhancements
  • Preparation of compliant design dossiers and technical files
  • Clinical Evaluation Reports for multiple markets including US, Europe, China, Australia
  • New Zealand WAND filings

Pharmaceutical and Biopharmaceutical Drug Products

  • Preparation for audits, preparation of regulatory files
  • Regulatory Guidances including FDA, ICH etc.
  • US NDA applications ineCTD format
  • Preparation of compliant regulatory files
  • Design Orphan Drug and Fast Track approaches
  • Develop Target Product Profiles
  • REMS
  • Develop advertising, promotion and labeling material
  • Perform mock inspections for both manufacturing and clinical sites
  • Audit CROs/CMOs
  • Coordinate Advisory Committee presentations
  • Guide Postmarketing Surveillance Programs

Compliance

  • Standards compliance, e.g. ISO 14971 Risk Assessments
  • Australian TGA ARTG registrations and conformity assessment submissions
  • Due diligence to assess regulatory compliance
  • Product and Establishment Registration and Listings
  • Medical Device Reporting
  • Corrections and removals
  • Recall Strategy Development
  • Post-approval studies
  • Inspectional observation responses (e.g. US FDA 483 observations)
  • Establish registration and device listings
  • Warning letter responses
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Caduceus Medical Development Ltd. offers a wide range of consulting services to Life Science companies

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