Being one of the effective online Regulatory systems, Saudi Arabia stands an easy-to-go-with market for medical devices, medicinal products and cosmetics’ registrations and approvals. However, the GCC’s (Gulf Cooperation Council) increasingly complex Regulatory requirements emphasize the need for manufacturers to be abreast with the rapid changes. The challenge for foreign manufacturers who are willing to enter Saudi Arabia is to track and sustain the changes to register and obtain approvals for their medical devices or cosmetics in a cost-effective way.

Freyr, being a global specialist Regulatory services provider, assists companies with the sustainable consulting for Regulatory affairs in Saudi Arabia. Freyr’s expert and dedicated regulatory teams enable clients with the end-to-end support for preparing and reviewing registration documents, manage SFDA submissions within regulated time-frames and thereafter obtaining health authority approvals.

Decoding all the regulatory requirements of the SFDA, Freyr navigates manufacturers through the necessary Regulatory procedures for registering their:

Freyr Offerings

  • Strategic Regulatory consulting
  • Regulatory affairs & Regulatory intelligence
  • License maintenance and registration
  • Market authorizations
  • Regulatory documentation and submissions
  • Labeling and artworks
  • In-country representation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase - with the SFDA and MoH
  • 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