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What we do
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Why Us?
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Special Promotion
What we do
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What we do
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
REGULATORY STRATEGY
DOSSIER REVIEW AND GAP ANALYSIS