Era Consulting


ERA has unparalleled level of expertise in the field of strategic regulatory consulting and over the last 24 years has supported over 500 biopharmaceutical products navigate regulations in Europe, USA, UK, Japan, Australia and Canada, including the first stem cell product to receive approval in Europe, Holoclar, where ERA’s support was credited with securing the fastest approval the EMA had issued for an ATMP.   ERA has extensive experience in working with viral vectors, gene therapy, gene editing and other leading edge technologies.  ERA takes pride in not just being experts in the following of regulatory guidelines and legislation but also utilising our skills to lay robust positions before regulators, including EMA, FDA, PMDA & TGA, that help shape the standards and practices for first in-class products.