We couldn’t have asked for a more professional, personable, knowledgeable group of Quality Experts!
Top 10 Pharma Company, China
Drug Safety Director
Drug Safety Director
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Who we are
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.
Local Contact
What our clients say about us
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.
In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.
Thomas Dobmeyer, CEO PharmaLex
CEO PharmaLexWhat was especially important to me was their ability to get a team, with the right experience, together so quickly.
Mid-size Biotech
Head of OutsourcingThere was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
Large Pharma, Global
VP Regulatory Strategy
