Quality & Regulatory Support
A pharmaceutical company required assistance with development and industrialisation of a drug delivery device.
Design control and regulatory requirements are subtly different for pharmaceutical products and medical devices. Internal processes often require modification to take this into account.
It is also true that many European suppliers of plastic and metal components have difficulty in meeting the expectations of pharma companies for documentation, systems and processes, largely due to the continuing pressures to reduce indirect costs in order to remain cost competitive.
42 Technology assisted the client by supplying complementary skills to interface with their own interdisciplinary project team.
| We were able to put a team on site, some part time and some full time, to assist with the following: |
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Development of the existing quality system for compliance with ISO13485 and FDA Design Control requirements. |
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Design and implementation of design verification and risk management plans |
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Work directly with suppliers of plastic and metal components to resolve quality problems and to validate manufacturing processes |
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Assist with the transfer of manufacturing and measurement techniques to overseas manufacturing sites |
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