In this dire time of the pandemic, we understand the need for quick-to-market, innovative products that can assist with the pandemic. We specialise in regulations of high-demand products like Rapid Antigen Test (RAT), Disinfectants, Hand Sanitisers, PPE (face masks, gloves, gowns etc.) and other medical needs and speciality products. We can assist with the complete package from testing through to registration. Our experts can assist clients in meeting the regulatory compliance for product launches in Australia, New Zealand, Asia, Europe, Canada and USA.
Throughout the pandemic, we have assisted number of businesses that are starting new ventures within the medical device space. We have assisted with the registration of a number of medical devices with the TGA and provided the necessary training to continue to meet the regulations.
We specialise in high-demand products such as Rapid Antigen Test Kit for COVID-19 (RAT Kits), also the multi-virus product such as Rapid Antigen Test Kits for COVID-19, Influenza A and Influenza B. We can pre-review all technical documents against the TGA requirements before submission to provide added confidence in the application process.
Our clinical research collaborators can assist with performing analytical studies, clinical performance studies and usability studies where needed. We can also assist with post-market review (S41JA) and advice on analytical work and clinical work for omicron variants.
