At Enimera, we specialize in crafting innovative regulatory approaches for the fast-moving biotech, pharmaceutical and wellness sectors.
Formed around the principles of integrity, innovation, and commercial success, we have a proven track record of enabling commercial success. We are experts in our field, agile in our approach, and deeply attuned to the commercial realities our clients face.
Our team blends scientific rigor with strategic foresight, delivering regulatory solutions to support speed-to-market and long-term business success.
Whether you’re scaling a novel therapy, advancing clinical research, or navigating cross-border approvals, Enimera is your strategic partner. Our team of regulatory experts and technologists works at the intersection of science, policy, and technology to help you stay agile, proactive, and fully aligned with global standards.
If you’ve identified compliance gaps or emerging risks, our experts can step in quickly to assess the situation, develop practical solutions, and restore regulatory confidence.
Regulatory expertise is at the core of our heritage, but at Enimera, we do more—that’s the “Plus” in RegsPlus. In addition to regulatory strategy and operations, we offer Pharmacovigilance and Quality Assurance services to pharmaceutical and wellness companies.
Our Team
We pride ourselves on the values of integrity, innovation and agility. We can operate as an extension of your team, or as a discrete operating unit so your team to focus on the busines as usual.
Director – Mary Nteris, PhD, GAICD
Mary formed Enimera RegsPlus 2018 after 20+ years Regulatory experience in the Pharmaceutical/Clinical trials industry. She has held senior roles in biopharmaceutical, clinical research and wellness organisations, led teams and led strategic initiatives, having oversight of Regulatory services in Australia, New Zealand and Asia. She is a Life Member and former President of ARCS Australia, a guest-lecturer to a number of post-graduate courses, and a mentor to post-graduate students through the IMNIS program.
Mary holds a PhD in Pharmacology, and is a Guest Lecturer at a number of highly-regarded Australian universities.
