At Nadu, we are proud to be at the forefront of nasal health innovation in Australia, driven by our unwavering commitment to rigorous development and excellence. Our journey in creating medical products reflects our dedication to ensuring that every product we develop meets the highest standards of safety and efficacy.
1. Research and Development (R&D): Our commitment to R&D is foundational to our mission. We engage in both basic and applied research to discover groundbreaking therapies and technologies for nasal health. With the support of Australia's esteemed research institutions, we foster an environment of innovation that is essential for advancing medical science.
2. Preclinical Testing: Before any product reaches human trials, we conduct thorough preclinical testing. Our promising candidates undergo rigorous evaluation in laboratory settings and assessing their safety and biological activity to ensure they meet our high standards.
3. Clinical Trials: Following successful preclinical results, we initiate comprehensive clinical trials in phases:
Phase I: We begin with a small group of healthy volunteers to meticulously evaluate safety and dosage.
Phase II: Next, we expand our trials to a larger group of participants to assess efficacy and potential side effects.
Phase III: Finally, extensive testing is conducted across diverse populations, confirming our product's effectiveness while monitoring any adverse reactions.
4. Regulatory Approval: Our dedication to quality is exemplified in our interactions with the Therapeutic Goods Administration (TGA), the governing body responsible for evaluating and approving medical products in Australia. We ensure that our clinical trial data is robust and comprehensive, meeting the stringent safety, quality, and efficacy standards set forth by the TGA. This process includes:
Conformity Assessment: We carefully determine the classification of our products and the appropriate assessment pathway.
Market Authorisation: Achieving inclusion in the Australian Register of Therapeutic Goods (ARTG) allows us to legally supply our innovative products in Australia.
5. Manufacturing: Once approved, our products transition to the manufacturing phase. We leverage Australia's advanced manufacturing facilities to produce high-quality medical products, including therapeutics specifically designed for nasal health.
6. Post-Market Surveillance: Our commitment to safety doesn't end with market entry. We engage in ongoing post-market surveillance to monitor long-term effects and rare adverse reactions. The TGA oversees this crucial phase, ensuring that our products continue to uphold our promise of safety and efficacy.
At Nadu, we are proud of the structured development process that we have established, bolstered by researchers, clinicians, regulatory experts, and manufacturers. Together, we are dedicated to delivering safe, effective, and high-quality nasal health products that enhance the well-being of our community.
