“For anyone seeking medical regulatory advice with regard to TGA or FDA compliance or who is considering launching a new medical device or pharmaceutical Anne’s assistance can be invaluable. Anne works seamlessly with an organization’s internal development teams to deliver results on time and above expectations. As CEO of Ausonex, I engaged Anne to support our business in developing a new medical device and commend her contribution.”
ACRA regulatory services as your Medical Device sponsor in Australia or New Zealand or in both countries
Acting on your behalf to register your medical device by communicating with either the Therapeutic Goods Administration (TGA) or Medsafe in New Zealand or both and carrying out obligations placed on the sponsor in relation to medical device or IVD device registrations, in order to meet and show compliance with the regulatory requirements in both countries.