PharmaLex Norway AS, previously known as Lindeq AS, has been a service provider within pharmacovigilance and clinical trial safety since 2004. In July 2016 we became part of the PharmaLex group. Our relationship with the global PharmaLex group enables us to provide a wider range of options in consulting, processing and support services, and since 2017 we also provide local regulatory consultancy in Norway.
We offer high competence and highly specialized consultancy services on local and global pharmacovigilance and regulatory activities. Our knowledge of the local market culture and authority expectations, is a key strength and helps us maintain our high success rate.
The local team performs the whole range of operational pharmacovigilance and regulatory services such as case management, literature review, medical writing, periodic safety update reports, risk management plans, SmPC translations, clinical trial protocol review, clinical overview addendum and much more. Norwegian PharmaLex employees hold the EU-QPPV role for several local and global companies and provide complete systems within pharmacovigilance. We are highly focused on quality and on being compliant with regulatory requirements, and our quality system is ISO 9001-2015 certified. We have wide experience with clinical trial safety and case management and are today involved in several global trials.
We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on contact@pharmalex.com.
