Qualification of Methodology Development

This is the stage in product development process for determining product design, e.g., performance and safety parameters. At this stage, we can also conduct validation tests on the selected materials and processes. Other services at this stage include but are not limited to:

 

    ● Updating of registration, regulatory strategy and competition evaluation

    ● Identification of clinical needs and validation

    ● Construction of quality management system for R&D and production (manuals and SOPs)

    ● Design risk analysis and failure modes and effects analysis (FMEA)

    ● Pre-clinical study strategy and protocol development

    ● Development and construction of surgical  and disease models

 

Harborside laboratory is a leading Chinese CRO concentrated on R&D testing and pre-clinical studies. We can help you achieve scientific, regulatory-compliant best outcomes at protype testing and pre-clinical verification stages of your products development.