Quality Assurance and GxP Compliance Services

Business driven compliance solutions, practical project management and cost effective resourcing solutions

Regulatory agencies expect that life science companies maintain effective QA, GxP, and validation programs and operate risk based quality management systems across all phases of clinical trials, technology transfer/scales up, manufacturing and post market surveillance.

SeerPharma is the leading life sciences professional consultancy service in Australia and Asia. Our teams of expert consultants deliver top level compliance advice and practical solutions, supported by industry training and knowledge transfer. Our managed resources offer the optimal balance of high level advisory services and cost effective project implementation.

International Resources: SeerPharma is able to resource and co-ordinate multi-site, QA, GxP and Validation programs locally and internationally and act as client QA representatives or compliance project managers.

• Gap analysis and audits to all standards such as FDA, EU, PIC/S, TGA, HSA, ISO13485
• CAPA programs and productivity improvement
• Compliance based risk assessments gap analysis and pre-approval audits
• Outsourced auditing programs
• Vendor qualification programs
• Pre- and post-audit regulatory support
• Quality Management Systems - development, implementation upgrades
• New facilities – GMP licensing
• Technology transfer oversight 

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