Regulatory



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