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Lindeq Products & Services

Lindeq

Lindeq offers comprehensive services comprising Pharmacovigilance (PV), Clinical Safety, Cosmetovigilance, Quality Management and Medical Device Vigilance. All solutions are customised to accommodate our client's individual requirements.

PV systems

  • QPPV package including all by the legislation required aspects
  • SOPs and Quality management systems
  • Electronic pharmacovigilance system master file (PSMF)
  • Pharmacovigilance system master file (PSMF)

Operational PV

  • Registration with EudraVigilance
  • Literature surveillance and review
  • Individual Case safety report handling
  • Electronic reporting
  • Risk management Plans (RMPs)
  • Preparation & maintenance of reference documents, incl. Company Core safety Information (CCSIs)
  • Aggregated reports, incl. Periodic safety update reports (PSURs)
  • Signal management
  • XEVMPD support
  • Medical Information
  • Medical review

PV related IT

  • Validation of computerised systems (PQ)
  • Data migration and mapping
  • Safety Database
  • EMA gateway testing
  • Quality management systems

Cosmetovigilance

  • Responsible person
  • Registration of products
  • Product Information File/cosmetic product dossier
  • Set up of a complete post-marketing surveillance of Serious Undesirable Effects
  • Reporting of Serious Undesirable Effects
  • Cosmetic products safety assessment (safety report)
  • Preparation and maintenance of consumer information and product labelling

Clinical Safety and PASS

  • Case management incl. database
  • Medical assessment of (S)AEs & SUSARs
  • Aggregated reports, incl. Development Safety Update Reports
  • Design and management of PASS

Medical Device Vigilance (MDV)

  • Set up and maintenance of complete MDV system, for all types of devices

Support

  • Ad hoc assistance when vacancies, work overload and narrow timelines
  • Audits
  • Preparation for Inspections
  • Assessment of risk/benefit
  • Medical qualified person
  • Medical consultancy
  • Expert statements
  • Pharmacoeconomic assessments
  • Ad hoc assistance
  • Training and education
  • Translations

Risk and Quality Management

  • All quality management needs in one systems software package
  • Management overview centre
  • Complete overview of document system
  • Web based (Cloud Service) – all IT services included
  • Flexible access control
  • Document approval workflow
  • Document versioning and change mark-up
  • Training with automatic documentation
  • Non-conformity and improvement reporting and monitoring
  • Data statistics overview
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