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What we do

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What Weir Regulatory Consulting can provide

Weir Regulatory Consulting can provide assistance with the following:

  • Regulatory strategy for timely product registration
  • Dossier review and gap analysis
  • TGA pre-submission meetings
  •  Preparation of dossier for registration with TGA and/or Medsafe, including NCE, NBE, literature-based (LBS) or hybrid submissions (Category 1 applications)
  • Major and minor variations including Category 3 applications
  • GMP clearance for overseas manufacturers
  • Guidance with technical transfers/change to manufacturing sites
  • Promotional and advertising advice including claim review, in line with Medicines Australia Code of Conduct
  • Medical device registration including Conformity Assessment and guidance with manufacturers evidence
  • Review of processes and procedures/SOPs
  • Guidance and interaction with Regulatory agencies
  • Orphan drug registration
  • Import permits including AQIS, controlled substances
  • Preparation of compliant labelling including PI, CMI and artwork