Regulatory

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Regulatory Affairs


Halmed’s consultants have over 15 years’ experience in regulatory affairs.

Extensive experience and liaison with TGA, we can offer initial regulatory strategy through to full registration applications for the Australian and New Zealand markets.

We offer expertise in:

  • Dossier evaluation & submissions
  • Re-scheduling submissions
  • PI, CPI and CMI development
  • Regulatory gap analysis

Let us handle and manage your registration applications for:

  • New Chemical entities
  • Generic Medicines
  • Over the counter (OTC) medicines
  • Medical Devices
  • Combination products