Overview

With positive economic prospects making the Spanish landscape favorable for investments, Spain stands a good bet for foreign medicine and medical device manufacturers. To enter the region, manufacturers must obtain approvals from The Spanish Agency for Medicines and Medical Devices, an authority oversees the registrations, licenses and pharmacovigilance across the region. With the Spanish Regulatory system quite specific about the Regulatory requirements, foreign manufacturers should be compliant ready before in-hand for successful and in-time market authorizations and approvals.  

Freyr, as a specialized global Regulatory partner, provides Regulatory affairs consulting across Spain enabling manufactures be compliant for product registrations and market authorizations in a timely manner. Freyr’s end-to-end Regulatory capabilities for Spain span across:

  • Medical Devices
  • Pharmaceuticals
  • Cosmetics
  • Food Supplements
  • Biologics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • Regulatory Submissions
  • Dossier preparation, review and management

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