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Professional Reports and Representative before Regulatory Authorities and in Court

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Response to Lists of Defects

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Expert Opinion and Representative before Regulatory Authorities and in Court

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Response to Lists of Deficencies

The Specialist for:

  • Planning clinical studies
  • Evaluation of clinical studies
  • Adaptive design
  • Response to lists of defects
  • Expert opinions and re-analyzes
  • Meta-analyzes
  • Audits for confirmatory pivotal studies
  • Representative of regulatory authorities

Also:

  • Work in accordance with guideline FDA 21 CFR Part 11
  • Work in a completely validated environment
  • Work conforming to GCP and ICH guidelines