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

  • Hege Rønning
    Managing Director - PharmaLex Norway PharmaLex Norway Karoline Kristiansens vei 1
    NO-0661 Oslo
    Norway
    +47 22 23 88 80

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.

  • I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

    Lorraine Henry
    Compliance Lead, Qualified Person, Amneal Ireland Limited
  • Hard working and there when you need them

    Europe based large biotech
    Regulatory Manager
  • They are available when we need to talk to them despite any time zone differentials

    Japan based medium sized company
    Manager
  • Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

    Leading European Specialist Pharma Company
    Head of Medical Writing and Publications