Regulatory Advice/Due Diligence

  • Consultation/ advocacy with relevant authorities and or other related organization/ institution on the Client’s case.
  • Reviewing regulation/ literature/ Client’s document.
  • Provide options and recommendation to Client.
  • Provide a roadmap of improvement/ establishment of Client’s project.

Product Registration/ Notification

  • Dossier screening and consultation to relevant authority with regards to the project.
  • Dossier preparation and uploading to online submission system (whenever applicable).
  • Submission and follow up, until the original certificate is obtained.
  • PIF establishment (for Cosmetics product).

License Holding (Local Authorized Representative/ Registrant)

  • Being the legal representative on behalf of the Client.
  • Maintain the validity of the product license.
  • Ensure the Distributor complies with the requirements of GDP.
    Manage field corrective action (i.e. : product recall, notification to relevant authority), adverse event reporting, communication with relevant regulatory authority, and manage Post Market Surveillance.
  • Performing importation, with the support of appointed freight forwarder and custom broker.

Distribution Services (Box Mover)

  • Warehousing
  • Logistic and Transportation
  • Inventory Management
  • Order Processing/ Invoicing and Correction

Quality Management System

  • A
  • B
  • C

Contract Manufacturing

  • Contract Manufacturing
  • Sterilization Services (ETO)
  • Packaging Services
  • Laboratory Services (Sterility Testing, ETO Residual Testing, Stability, etc)

Other Services

  • Clinical Trials
    • Getting Ethical Committee Approval
    • Getting Special Access Scheme from MoH
    • Performing the importation
  • Halal Certification
  • Translation
    • Medical Translation
    • General Translation
  • After Sales Service
    • Servicing and Maintenance Medical Equipment