Regulatory Services / Contract Staffing

Regulatory Affairs is the key function for establishing new products as well as maintaining the product portfolio. It ensures that the business is performed safely, in line with prevailing laws, and with the highest quality.

Regulatory Affairs is Sofus’ speciality - we have wide competence and the experience that is necessary to be a high-performer in this area.

Contact
Linda Thunell, CEO
tel: +46 8 5600 2002, linda.thunell(at)sofus.se



  • NDAs/Variations/Renewals
    Sofus can assist your company with all the regulatory procedures within the EU (Centralised, Decentralised, and Mutual Recognition) and the National Procedures within the Nordic area.
  • Text and labelling
    We handle projects that range from creating labelling documents and pan-Nordic packs to qualified translations. We can also assist you with the practical management of your texts (see also Readability Testing).
  • Contract staffing
    We provide qualified consultants for short and long term contract staffing within all our service areas. Whether you need temporary support or long term solutions, we are available and ready to assist you.

  • Portals/Catalogue texts
    We assist companies on-site from our offices with NPL, Fass, Felleskatalogen, Pharmaca Fennica and Laegemiddelkataloget/Medicinhåndbogen

  • Complete Regulatory Solutions
    • Sofus can take care of the full spectrum of services including Regulatory Affairs, Medical Information, Pharmacovigilance, and Pricing and Reimbursement, and act as your company’s Regulatory Representative within the Nordic area.
    • Sofus can in-source parts or whole of your Regulatory Affairs functions.