PHARMACEUTICALS & MEDICAL DEVICES SECTOR

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Insights

Innovation and continual improvement throughout the product lifecycle; and strengthening the link between pharmaceutical development and manufacturing organizations is essential to pharmaceutical sector.

How Do We Help

Advisory on establishing ICH Q10 – Pharmaceutical Quality System is the key support we provide to our clients. As a part of ICH Q10 we aim at developing a comprehensive quality system over the lifecycle of the product to achieve product realization, establish and maintain a state of control and facilitate continual improvement.

We assist our clients to ensure their medical devices meets regulatory requirements and the CB Schemes, as well as comply with global health and environmental requirements and restrictions, such as RoHS.  We have a committed medical Management Systems Certification team to fully integrate the compliance solutions based on Supplier audits, gap analysis audits, pharmaceutical GMP audits

Our people

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