Overview

Being in an unprecedented position for boosting life sciences industry’s productivity, Australia offers medicines and medical device’s manufacturers a great deal of opportunities while investing in the region. To access the market, manufacturers must obtain market approvals from Therapeutic Goods Administration (TGA) - Australia Government, Department of Health. Apart from handling wide variety of complex manufacturing and clinical functions, navigating through critical Regulatory processes and TGA requirements for various medicines and medical device categories might pose a great challenge for manufacturers while approaching for market authorizations.

Freyr, as a global Regulatory solutions and service provider, keeps track of Australian life sciences Regulatory requirements and assists manufacturers to navigate through the procedural challenges like dossier preparation, validation, and submissions. Freyr’s Regulatory services in Australia span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Regulatory Submissions
  • CTD, eCTD, NeeS
  • NeeS to eCTD conversions
  • Dossier management
  • Gap Analysis
  • Variations and Life Cycle Management
  • CMC
  • Medical Writing
  • Pharmacovigilance
  • The traditional herbal medicinal products registration

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with TGA, Therapy Recruitment Administration and MedSafe
  • Team with 25+ years of strong foothold in the region
  • Proven track record for device registrations and submissions
  • End-to-end cosmetic Regulatory consultation
  • Structured and cost-effective approach to ensure speed to market