Equipment, Facility and Computer System Projects
At GMPharma, expert Qualification and Validation services are provided. The latest risk-based Computer System Validation (CSV) methodologies are applied to ensure systems are fully prepared for inspections by regulatory authorities such as the Therapeutic Goods Administration (TGA), U.S. Food and Drug Administration, European Medicines Agency, and Medicines and Healthcare products Regulatory Agency, as well as other global regulators. Supported by a strong background in scale-up and development across the pharmaceutical, biotechnology, medical device, clinical research, and software sectors, compliance is effectively maintained.

GMP Readiness and Audits
Comprehensive audit services across various GxP areas are delivered globally, including gap analysis and risk assessment. Multilingual team capabilities are leveraged to improve efficiency and reduce costs. Auditors possess extensive expertise across the full development and regulatory lifecycle, ensuring GMP readiness in alignment with Pharmaceutical Inspection Co-operation Scheme, EU regulations, and ISO standards.

Quality Management System (eQMS)
Hands-on support is provided for the implementation and optimisation of QMS tools (including Change Control, CAPA, NCR, etc.) in accordance with quality system requirements and standards. Drawing on extensive consulting and operational experience, processes are effectively navigated, CAPA systems are robustly supported during regulatory inspections, and overall program performance is optimised.