We are regulatory consultants who provide expert medical device and IVD regulatory guidance to help launch products and access new markets.

Service include general regulatory advice to product registration in order to access different markets including

  • Australian (TGA),
  • EU (CE Marking),
  • United States (FDA),
  • Canada


Our Clients

We pride ourselves on providing excellent customer service.

Care Essentials
Opto
Elastagen
Brauer Natural Medicine
Australian Dental Manufacturing
Signostics