Regulatory consultants
to the pharmaceutical industry

Our Services

A full range of market authorisation submissions for prescription and OTC medicines including:

  • Dossier gap analysis
  • Agency and pre-submission meeting representation
  • Orphan drug designations and submissions
  • Literature based submissions
  • NCE, biologic and generic medicines
  • Rescheduling applications
  • Product Information (PI) and Consumer Medicine Information (CMI)
  • Labelling

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    Medical device applications including:

  • Class I, IIa and IIb devices
  • Class III devices
  • Conformity assessments

    • Other Services:

  • Regulatory advice during product development
  • GMP applications
  • Export listings
  • Certificate of Pharmaceutical Product (CPP) and Certificate of Free Sale (FSC) applications and coordination of their legalisation/notarisation
  • Import permits
  • Clinical trial notifications
  • Advertising reviews
  • Government liaison
  • Quality management
  • Quality systems setups
  • Pharmaceutical warehousing licences
  • Sourcing Australian sponsors
  • Staff coaching
  • Scientific writing
  • Proofreading