Do you manufacture therapeutic or veterinary goods? As you’re aware, you need to comply with the quality systems regulated by the Therapeutic Goods Administration, the APVMA and/or the Pharmaceutical Inspection Co-operation Scheme (PIC/S). We can develop your procedures and manuals that ensure you comply with the regulations, as well as conduct deficiency response audits and train your staff.

Assistance in establishing compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). Other associated services include:

• Facility design and licensing

• Pilot batch manufacture

• Facility upgrades and improvements

• Validation Master Plan (VMP) and execution

• Quality Assurance (QA) and Quality Management Systems (QMS)

• Audits and inspections

• Equipment qualification

• Process validation

• Analytical method validation

• Contamination control

• Product Quality Reviews

• Release for supply