Lindeq Products & Services

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