Quality Management



Authorities in all countries continually formulate new regulations designed to ensure the safety of medicines and other medical devices.

Moregate BioTech ensures continuing compliance with global regulatory authorities on all products.

Source material is obtained from large and efficient slaughter houses, utilising the most aseptic collection methods according to EU and USDA standards. They are regulated by National Government Agencies which place inspectors at the abattoirs to audit and supervise the daily operations of the abattoir's quality system.

Moregate BioTech's processing systems are operated according to cGMP in modern purpose built facilities. These systems are designed and operated in a manner that ensures conformity to regulatory requirements.

The quality systems are approved by the New Zealand Ministry of Agriculture and Fisheries (NZMAF) and the Australian Department of Agriculture and Water Resources (previously DAFF), which also audit quality systems.

Both agencies issue Export Animal Health Certificates in their respective countries.

All major products manufactured by Moregate BioTech have had dossiers submitted to the European Directorate for the Quality of Medicines (EDQM) and have received Certification of Suitability of Monographs of the European Pharmacopeia.

Certificates of Suitability can be provided on request.

Moregate Biotech has been granted a COS for:

Fetal Bovine Serum – Australian Origin – CEP2000-187
Fetal Bovine Serum – New Zealand Origin – CEP2000-188
Adult Bovine Serum - New Zealand Origin – CEP2001-093
Adult Bovine Serum (Defibrinated) - New Zealand Origin – CEP2000-174
Bovine Plasma – New Zealand Origin – CEP2003-199
Bovine Serum Albumin – manufactured in Australia from New Zealand origin Bovine Plasma – CEP2003-205
Bovine Plasma – Australian Origin - CEP 2005-192
Bovine Serum Albumin – manufactured in Australia from Australian origin Bovine Plasma - CEP 2005-191