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Regulatory support

 

Input on current and future regulatory issues and the impact on programmes, incl, device requirements, extractables and leachables etc. Device Drug Master File (DMF) strategy, architecture, generation and management. Activities have included;

  • Audit/ Review/ gap analysis on Type III device Drug Master Files (DMFs)
  • DMF design and preparation.
  • Material selection and approval strategies.
  • Co-ordination of Extractables and Leachables activities. 
  • Input on Validation Master Plans. impact assessments etc.
 
 

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