Overview

With a growing Pharmaceutical / Medical Device manufacturing sector, New Zealand seems to be the potential bet for manufacturers across the globe to commercialize their medicinal products and devices in the region. While doing so manufacturers must comply with the region’s regulatory authority –The New Zealand Medicines and Medical Device Safety Authority (MedSafe) and for medical devices they should list their products in the Web Assisted Notification of Devices (WAND), no later than 30 days of exporting. Though manufacturers are free from obtaining pre-market approvals to enter the region, the proposed legislation changes and the willingness of New Zealand government to overhaul its existing Regulatory system might deviate market entrants with unclear Regulatory requirements.

Freyr, as a specialized global Regulatory partner, assists foreign manufacturers to keep track of update Regulatory requirements in the region and provides end-to-end Regulatory services in New Zealand that span across:

  • Medical Devices
  • In-vitro Diagnostics
  • Prescription and Non-Prescription Medicines
  • Complementary Medicines
  • Veterinary Products
  • Dietary Products

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Marketing Authorization Applications,
  • New Medicine Application preparation and submissions
  • Handling and maintaining notification process
  • On-site training on the WAND (Web Assisted Notification of Devices) database
  • End-to-end assistance with investigation of medical device adverse events
  • Good Manufacturing Practice (GMP) and GLP
  • Product Labeling and advertising support
  • CMC NDA, ANDA, CTD, dealing with post-approval changes – SUPAC
  • Regulatory Submissions and follow-up
  • handling and maintenance including electronic documentation (21 CFR part 11)
  • Preparation of SPCs, Pack inserts, Product rationale,
  • Preparation of PSUR reports
  • DMF compilation
  • Medical writing
  • Post-market Activities, Post Marketing Maintenance

Freyr Advantage

  • Strategic local health authority contacts – with Medsafe
  • Expert Regulatory team with 25+ years of strong foothold and proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines