Regulatory

The KGIBD team has comprehensive expertise with the registration process required by the Australian Therapeutic Goods Administration and New Zealand’s MEDSAFE system.

If you are planning to enter the Australasian market, KGIBD is able to provide full product registration service with a flexible support structure, giving you the opportunity to tap into multiple distribution channels.

Benefits are:

  • Fully independent registration held by a non-distributor legal entity;
  • You, the client, have full control of your registration;
  • Greater market flexibility with access via your choice of distributors;
  • Easy-to transfer agency agreements;
  • Product recall facilitation; and
  • Complaints handling and compliance reporting.

KGIBD offers:

  • Comment on entering international markets;
  • Registration lodgement, documentation, and progress tracking;
  • Knowledge and support on specific market regulatory requirements;
  • Annual registration requirements;
  • Ongoing administration;
  • Product recall facilitation; and
  • Complaints handling and compliance reporting.

To learn more about taking control of your own registrations, contact our team for a free half-hour needs analysis consultation.