Hard working and there when you need them
Regulatory Manager
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.
Hard working and there when you need them
There 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.
PharmaLex is dedicated to delivering a comprehensive portfolio while their modular approach allows tailor-made solutions. They acknowledge our feedback, modify their approach and adapt accordingly.
Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.
We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for
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In compliance with the Spanish Law 15/1999, of Protection of Personal Data and in accordance with regulations approved by the Spanish RD 994/1999 inform you that your data will be part of a file located in Friedrichsdorf (Germany), whose ownership belongs to Pharmalex Spain S.L.U. The purpose of these data is the insertion in a potential job selection process. Inform the user that at any time may exercise their right of access, rectification, and deletion of data through email curriculum@pharmalex.com or to this postal address Pharmalex Spain. Coso 103, 50001 Zaragoza, Spain.