Reference safety documents: CCDS, CCSI, SPC, PIL

Reference safety documents (US: labelling documents) like CCDS, CCSI, SPC, PILs have to be regularly revised and updated as needed. At Lindeq we have long-term experience with updating the reference safety documents, both internal documents like the CCDS and the CCSI as well as regularly documents like the SPC and PIL.

Furthermore, we can translate Reference safety documentation to all Scandinavian languages plus Dutch, Finnish, French, German, Greek, Hindi, Italian, Lithuanian, Portuguese, Russian, Spanish, and Tamil.

 

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.




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Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
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Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
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Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
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Quality Management System
Web-based quality management system software including training and document management
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Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
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Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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Cosmetovigilance
Full range of cosmetic product safety services for all different types of cosmetic products
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Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)