Overview

With an advanced healthcare system and growing opportunities for private healthcare providers, Sweden offers a good deal of investment opportunities for foreign medicines and medical devices manufacturers. For the market access, manufacturers must obtain authorizations from Medical Products Agency, the Swedish national authority overlooking the regulations and registrations. With the complex Regulatory requirements, foreign manufacturers might face certain Regulatory procedural challenges while approaching for Swedish market authorizations.

Freyr, as an exclusive global Regulatory Solutions and services provider, assists manufacturers to navigate the necessary Swedish Regulatory documentation, submissions for successful registrations and market approvals. Freyr’s end-to-end Regulatory affairs consulting in Sweden span across:

  • Medical Devices
  • Pharmaceuticals / Drugs
  • Cosmetics and Food Supplements
  • Biologics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Strategic business development focusing on the European market
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Market assessments
  • In-country representation 

Freyr Advantages

  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines