Overview

Situated in Central Europe, Poland stands a good access point for other regions in Europe. In addition, Poland’s steadily growing economy predominantly boasts a good fortune for foreign medicine and medical devices manufacturers for investments. However, the health sector is highly regulated and the Ministry of Health oversees the regulations regarding necessary market authorizations and market approvals. In addition, lack of profound knowledge on local regulatory rules would pose a great challenge for manufacturers to sail through the approval procedures.

Freyr, as an exclusive global Regulatory partner, assists foreign manufacturers to navigate through complex Regulatory procedures in Poland. Right from invaluable market insights to obtaining end-to-end market authorizations, Freyr’s Regulatory services in Poland span across:

  • Medical devices
  • NCE’s/Generics
  • Cosmetics
  • OTC
  • Food & Dietary Supplements

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Marketing authorizations maintenance: Variations, renewals, notifications
  • End-to-end Regulatory submissions
  • Preparation of eCTD and NeeS and dossier publishing
  • Dossier Management, Dossier Audit
  • Consultancy services for European procedures (MRP, DCP) and national procedure
  • PIL readability testing/PIL user testing according to EU guidelines
  • Preparation and translation of Summary of Product Characteristic (SmPC)
  • Patient Information Leaflet (PIL)
  • Labelling including Braille
  • ICH-Good Compliance Practice (GCP)
  • CE Marking
  • Pharmacovigilance

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