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REGULATORY AFFAIRS

REGULATORY AFFAIRS
Product Description

- Regulatory support
- Political and social scenarios analysis within the Brazilian Health Sector- Market analysis to provide strategic information on the Brazilian Health System including public and private sectors
- Regulatory intelligence strategy
- Compliance
- Due diligence
- Preparation of CADIFA (Letter of suitability of the active pharmaceutical ingredient)
- Project managements and regularization

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Unica suporte científico e regulatório

  • BR
  • 2019
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Primary activities
Clinical Research
Other
Regulatory Affairs
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Categories
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Specifications
  • Supplied from
    Brazil
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Sales Markets
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Unica suporte científico e regulatório

  • BR
  • 2019
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Primary activities
Clinical Research
Other
Regulatory Affairs
View company profile

More Products from Unica suporte científico e regulatório (2)

  • GOOD MANUFACTURING PRACTICES

    Product GOOD MANUFACTURING PRACTICES

    - Quality Audits
    - Risk assessment and management
    - Review of Documents
    - Training
    - Preparation of technical reports

  • CLINICAL RESEARCH

    Product CLINICAL RESEARCH

    - Support for strategic evaluations and regulatory alignment on clinical trials
    - Qualification of study centres and researches
    - Preparation of research protocols
    - Preparation of Clinical Drug Development Dossiers (CDDDs)
    - Monitoring of clinical studies
    - Review of scientific literature

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