You can outsource the following work to MAx:

Regulatory

Outsource to us your entire handling of SmPC, PIL, labelling, mockups and artwork for all the Nordic markets. We offer drafting and QC of English PI for new medicinal products as well as the full range of LCM maintenance activities. We offer high quality translations services for all the Nordic countries.

We are experts in management of Artworks for Nordic combined packs. Outsource your entire handling to us, from mockups to final printed artwork. We guarantee speed of delivery and 100% quality and compliance. Let us take care of the correspondance between manufacturing sites and grapical designers. Let us manage the bill of materials in your ERP system.

Auxillary services are offered in the form of maintenance of medical databases like FASS, DKMAnet and Felleskatalogen.

Promotion Material

Outsource your promotion material compliance review for Sweden and Denmark. Our consultants are trained in the Lif ethical code through Läkemedelsakademin.

Pharmacovigilance

We offer Pharmacovigilance GVP Audit of MAH and service providers – onsite or online. We travel worldwide

• Literature Monitoring – Global and Local

The above services are ready to start immediately. Please reach out to martl@maxregconsult.com for a non-binding offer.

Early Development

Through our world-leading CRO partner we can offer a range of efficacy and safety studies in Zebra Fish, both under GLP and non-GLP conditions.