Pillar 2: Life Cycle Management

Pillar 2: Life Cycle Management
Product Description

Central and Local Outsourcing Operating ModelPromotional Materials
Product Marketing Authorization and Life Cycle Management
Pre Marketing Approval Support
Interaction with Global Health Authorities
Health-Care Compliance – France
Regulatory Intelligence & Strategy Building

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ProductLife Group

  • Country/Region:
    France
  • On CPHI since:
    2023
  • Certificates:
    1
  • Employees:
    1000 - 4999
Company types
Consultancy
Primary activities
Other
View company profile
Categories
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Specifications
  • Details
    REGULATORY AFFAIRS AND OPERATIONS
    • Regulatory Affairs
    • Regulatory Operations


    CMCQUALITY AND COMPLIANCE
    • Quality Assurance and Qualified Person Services
    • Quality Management System (QMS) & GxP Audit Services
    • Engineering Consulting, Qualification & Validation Services


    SAFETY AND VIGILANCE
    • QPPV and Local Safety Officer/Responsible Person
    • Medical Information (MI)Literature Monitoring
    • Individual Case Safety Report (ICSR) Management
    • Aggregate Report and Risk Management Plan
    • Signal Management
  • Model
    Consulting
  • Measured In
    Euro
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Sales Markets
Show more Show less

ProductLife Group

  • Country/Region:
    France
  • On CPHI since:
    2023
  • Certificates:
    1
  • Employees:
    1000 - 4999
Company types
Consultancy
Primary activities
Other
View company profile

More Products from ProductLife Group (2)

  • Pillar 1: Product Development

    Product Pillar 1: Product Development

    Our services for Quality & Compliance:

    - CMC Pre and Postapproval
    - Quality Systems Consulting and Operational Quality Assurance
    - Audits and Inspection Readiness
    - Management of Compliance



  • Pillar 3: Strategy & Digital

    Product Pillar 3: Strategy & Digital

    Our services for vigilance & Safety:EU QPPV and LPPV/LSO
    Pharmacovigilance Consulting
    Case Management
    Regulatory Medical Writing
    Medical Information
    Literature Watch
    Cosmetovigilance
    Medical Devices and IVD Vigilance

ProductLife Group resources (2)

  • Product Development Trends for a Changing Market: Breakfast Session Bulletin

    News Product Development Trends for a Changing Market: Breakfast Session Bulletin

    Throughout CPHI North America 2023, several Breakfast Sessions were held to start the day off right with a complimentary breakfast and a networking and learning session for our attendees. With insightful presentations from industry experts and partners, the CPHI North America Breakfast Sessions had something for everyone looking to fill their brains and their stomachs.    

    9 May 2023
  • ARTIFICIAL INTELLIGENCE (AI) IN PHARMACOVIGILANCE: DO WE REALLY NEED IT…?

    Whitepaper ARTIFICIAL INTELLIGENCE (AI) IN PHARMACOVIGILANCE: DO WE REALLY NEED IT…?

    There seems to be a lack of clarity about the meaning of terms such as “artificial intelligence (AI)”, “machine learning (ML)”, “data science (DS)” and “office automation (OA)”, which should not be used interchangeably. Pharmacovigilance (PV) represents a very interesting field in this regard, since it poses some unique technical challenges. For example, the “signal to noise ratio” and the “quality of the information” are very different in reports from clinical trials and in information coming from social networks, smartphone apps or smartwatches, and therefore require different approaches. Case processing, moreover, requires a mix of administrative and repetitive tasks (e.g. data cleaning and form filling) and tasks that require a high level of experience and specialization (e.g. medical reviews and signal detection). For more information, contact us.