Member Directory

Enimera RegsPlus

Website: https://enimeraregsplus.com.au/

Member Contact: Dr Mary Nteris

Position: Director and Consultant

Industry: Industry Support Services

Company Profile:

Enimera RegsPlus is an Australian owned consultancy providing regulatory and related services to Australian and overseas organisations.

We have over 25 years industry experience covering the therapeutic development, advocacy, and regulatory filings both in Australia, US, Europe and other regions.

We are experts in US FDA and EMA Orphan Drug Designations, and at identifying fast-track regulatory pathways.

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BioMelbourne Network respectfully acknowledges the Traditional Custodians of the unceded lands and waters of Victoria: the Bunurong, Gunaikurnai and Wurundjeri peoples, on which the BioMelbourne Network and our Victorian members work, and as well as the lands and waters of our members further afield. We pay respect to their Elders past and present. As Australia’s first scientists, we acknowledge the significant contribution that they and other Aboriginal and Torres Strait Islander people have made and continue to make to the research and knowledge systems that inform our community and our sector.

We acknowledge that Aboriginal and Torres Strait Islander people continue to live in a spiritual and sacred relationship with this country and recognise our responsibility to continue to work towards reconciliation.