Our experience from creating and updating product information texts leads to high quality texts that follow the correct templates and guidance documents. This will facilitate the authority review process and can lead to faster variation approvals.
The Summary of Product Characteristics (or SmPC) is the most important regulatory document, summarising all relevant data on your medicinal product. Along with the patient information leaflet (PIL) and the labelling it is a tool for the safe and effective use of a product, as well as the basis of any promotional activity.
Whether you need to create new product information in all Nordic languages, or if you just need help with reviewing artwork updates or translations for variations, we can help. Outsourcing this step to Arex Advisor can create efficiency gains and reduce workload for your regulatory teams.
Examples of services provided by our team:
Labelling expertise and regulatory strategy
Lovisa Rosenquist
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
