Other Capabilities

Other Capabilities

GMP Consulting

• Including facility design
• Equipment procurement
• Audit gap analysis

Validation

• Equipment, services and facilities to EU, FDA and TGA requirements
• Including URS, DQ, IQ, OQ and PQ

Quality Assurance

• Including audit closeouts
• Implementation of quality systems such as CAPA, change control and deviations
• Quality document review including SMP, VMP etc

Project Management (PMI)

• Project Management
• Implementation of Project Management systems

Regulatory Affairs

• Including new product registration
• Regulatory submissions
• GMP compliance