We have had the pleasure of working with Mary and her team for the last 5 years and can confidently say that their professionalism, expertise, and customer-centric approach set them apart. Their deep understanding of Australian regulatory framework, combined with their ability to listen and provide pragmatic, tailored solutions, has been invaluable to our business. What truly stands out is their commitment to finding efficient and effective pathways through sometimes complex regulatory landscapes. They approach every challenge with a solutions-driven mindset, ensuring compliance while keeping practicality in focus. Their responsiveness, thoroughness, and ability to translate regulatory requirements into actionable steps make them a trusted partner in navigating regulatory & compliance matters. We highly recommend ENIMERA REGS+ to anyone seeking knowledgeable, strategic, and customer-focused regulatory support in Australia.
- Managing Director
Our Regulatory Partner for Australia and New Zealand We are extremely satisfied with the support provided by Enimera for our submissions in Australia and New Zealand. They keep us well-informed about the country-specific requirements that we need to consider for our submissions. This includes guidance on country-specific documents that we need to provide, as well as detailed information on regulatory timelines. What stands out the most is their quick response time to our inquiries and their open communication. This greatly facilitates our collaboration and ensures that we are always well-informed and prepared. We highly value their expertise and advice!
- Quality and Regulatory Affairs Director
Enigmera RegsPlus is a very professional regulatory consultancy, and I have found working with them to be a great experience. When working together, I received a very prompt response, including detailed information compiled from scratch about how to register my company’s product in Australia. The team was very willing to provide guidance to ensure we were prepared for the questions and data requests that were likely to be raised by authorities. The team is customer oriented, responsive, detailed and supportive. They never over promised, but their vast experience and expertise helped us to get the approval we needed on time!
- SEA Business Development Manager
Enimera RegsPlus applied strategic and innovative thinking to two new prescription medicine applications on behalf of [Company] which saved us significant time and costs leading to positive outcomes.
- Managing Director
Enimera RegsPlus applied strategic and innovative thinking to two new prescription medicine applications on behalf of [client] which saved us significant time and costs leading to positive outcomes.
- Managing Director
In general, medicinal cannabis and cannabis-based products face regulatory challenges. After navigating in various jurisdictions, we found in Enimera Regs+ and particularly in Mary Nteris a true partner with whom facing such challenges has resulted in well-crafted regulatory strategies. Enimera excels in allowing a foreign company like ours to understand and embrace the regulatory landscape in Australia.
- Director of Regulatory Affairs and IP