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Quality and Regulatory in Life Sciences
Products & Services
Product Development
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Signifix has expertise and can provide consultancy services in
the following areas:
  • Project management in product development of biomedical products
  • Providing advice and support on product and process design & development including:

    • Assessment and definition of product requirements
    • Defining design and development testing to be performed (biological safety, biocompatibility, physico-chemical, stability, validations, product functionality)
    • Management of risk management processes
  • Development of final product packaging and product transport systems for cell technology therapies
  • Implementation of Design Control principles
  • Process design, implementation and optimization to meet requirements such as GLP and GMP
  • Process validation of manufacturing processes
  • Transfer of R & D processes into commercial GMP production processes
  • Writing or reviewing technical documentation (protocols and reports including raw data) such as:

    • R & D study protocols and reports
    • Pre-clinical protocols and reports
    • Validation protocols and reports
    • Stability protocols and reports
  • Interim management of manufacturing operations
  • Training and coaching: customized PD training programmes for individuals and groups