Quality Services & Consulting - Acrux has a strong culture of integrity, quality and excellence
- Quality compliance and due diligence auditing of Contract Manufacturing Organisations (CMOs), analytical testing laboratories, API and excipient manufacturers & technical service providers
- Quality Management System design, implementation, management & compliance auditing
- Quality audit (virtual & on-site) preparation, training, oversight & response management eg: TGA, FDA
- Validation: facilities, instrumentation, lab equipment, QC & in-vitro test methods and software
- Data integrity: Verification of published and non-published research data and discovery claims
- Data integrity: Process workflows, risk assessments and controls
- Investigation management: Including OOS, deviation & product recalls
- Raw material and finished products batch release
- Oversee compliance of In-Vitro GLP studies
Customised Training Services
- GMP & GLP Principles
- Quality Investigations
- Technical and procedure writing
- Other customised training