PR Regulatory Services

Outsorcing is another alternative way of acquiring top talent when you need it and keep flexibility in the organization. Using the outsourcing model, you focus on your core business and let us take care of parts that we are better placed to handle.

Outsourcing is normally more long term in nature, we normally lead and manage the team, the scope of work and targeted results are agreed beforehand and we are followed up on our ability to deliver according to plan. Outsourcing may be about having access to talent you would normally not be able to afford, but sharing resources with others make it possible.



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Our In-house Regulatory Affairs department meets your needs within the wide area of Regulatory Affairs. We have long experience in all aspects of regulatory, pharmacovigilance, QA, medical translations. The In-house department is headed by Helena Björkman with 20 years of experience in the regulatory field, last 10 as a senior executive and with the network that you need.

PharmaRelations provide a wide range of regulatory services; e.g. FASS, Felleskatalogen, Pharmaca Fennica, DKMA-net, vnr, LiiV, Farmalogg, translations into Swedish and Norwegian, mock-ups and labelling, variations and renewals, QC checks, coordination, database maintenance, classification, OTC-switches, new applications, regulatory strategies, medical writing, audits, CMC-support and regulatory intelligence from an ever-changing pharmaceutical landscape. We can act as your local Regulatory Affairs Department or we support your first steps on the Nordic markets. PharmaRelations provide a custom-made flexible solution for your needs; part-time, full-time, long term, short term, peaks, projects and Ad-hoc solutions to allows you to focus and get results as quickly as possible.

PharmaRelations is your Nordic Regulatory Affairs partner

- Insourcing and outsourcing of regulatory consultants or recruitment of regulatory staff
- Flexible, efficient and high quality services
- Nordic partner - Offices in Stockholm, Copenhagen, Helsinki and Oslo
- Deep knowledge of the local Swedish and Nordic regulatory landscape
- PharmaRelations has a long experience and knowledge from working within the pharmaceutical industry

Outsource all or parts of your QA and PV to PharmaRelations

In order to focus on your core activities and have access to specialists in different areas, you may outsource parts or all of your ”Life cycle” QA/PV to PharmaRelations. 

We have the  competence to handle  both pharmaceuticals and Medtech devices. Our professionals take responsibility for the parts you chose to outsource, we work in our offices or in your premises, as best suited. We work in your systems.

To find out more about our services and solutions please contact;

Helena Björkman, Head of Regulatory Affairs Sweden and Nordic coordinator
helena.bjorkman@pharmarelations.se, +46 (0)70-165 22 77

Lisbeth Thyregod, Head of Regulatory Affairs Denmark
lisbeth.thyregod@pharmarelations.dk, +45 4130 8660