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Unica suporte científico e regulatório

About Unica suporte científico e regulatório

In this edition of CPhI 2023, in Barcelona, ​​Única Suporte and B2CD will be together! A collaborative connection between two partner consultancies, with solid technical, strategic and specialized knowledge, in all segments regulated by the Brazilian health authorities - ANVISA and MAPA.
We offer a complete hub of services for drugs, cannabis products, cosmetics, foods, sanitizers, medical de...

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  • Country/Region:
    Brazil
  • On CPHI since:
    2019
  • Employees:
    1 - 24
Company types
Consultancy
Primary activities
Clinical Research
Other
Regulatory Affairs
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Products from Unica suporte científico e regulatório (3)

  • REGULATORY AFFAIRS

    Product REGULATORY AFFAIRS

    - 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
    -...
  • 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