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Detailed Description of Pharmacovigilance System (DDPS)
PV post marketing
Registration with EudraVigilance (EV)
Literature surveillance and review
Case Processing and Report Management
Electronic reporting (E2B)
Risk Management Plans (RMPs)
Company Core Safety Information (CCSI)
Periodic Safety Update Reports (PSURs)
Signal generation and signal detection
Risk Management
Labelling
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Annual Safety Report
Development Safety Update Report (DSUR)
Serious Adverse Event (SAE) Management
Medical Assessments of Serious Adverse Events
Design of data entry applications
Data Management
Design of queries/reports from drug safety and clinical systems
Clinical dictionary management
System implementation/upgrade projects
Management & Implementation of ICH E2B ex- and imports
Quality systems
Quality Systems
Web-based Quality Management System AptQMS
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Pharmaceutical industry
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IT solutions
Outsourcing of PV with integrated IT solutions
Web-based Quality Management System AptQMS
Web-based validated safety database
Migration of full system data or coding systems
Validation
Management & administration of drug safety and clinical systems
Contract negotiations with system vendors
GxP Computerised Systems Validation (CSV)
MedDRA upversioning impact control & documentation
Compliance (reporting) tracking applications
Computerised System Audits
Medical Device Vigilance
Medical Device Vigilance
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Education and Training
Training: MedDRA coding, later retrieval of MedDRA coded data & SMQs
Audits and Inspections & Computerized System Audits
Assessment of Risk/Benefit
System vendor selection process & projects
Contract negotiations with system vendors
URS, RfP and SOP authoring
GxP Computerised Systems Validation (CSV)
Management & Implemantation of ICH E2B ex- and imports
MedDRA upversioning impact control & documentation
Compliance (reporting) tracking applications
System implementation/upgrade projects
Certified MedDRA coding and querying
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Individual Solutions
Human factor approach
Human Factor Approach
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Lindeq_2011.pdf
modern quality management system AptQMS
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Outsourcing of PV with integrated IT solutions
Web-based Quality Management System AptQMS
Web-based validated safety database
Migration of full system data or coding systems
Validation
Management & administration of drug safety and clinical systems
Contract negotiations with system vendors
GxP Computerised Systems Validation (CSV)
MedDRA upversioning impact control & documentation
Compliance (reporting) tracking applications
Computerised System Audits
Info
Web-based validated safety database
Please contact us for further information.
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