ERA Consulting is a leading independent regulatory affairs and product development consultancy specialising in complex biotechnology-related medicines, and assisting with preclinical services.ERA's Australian office was established over 10 years ago. ERA was the first global biotech/pharma consultancy to inwardly invest in Queensland. A specialised team of more than 30 professionals, including scientists with R&D and industry experience and former regulators, is spread throughout ERA's offices worldwide. ERA Consulting (Australia) specialises in phase I clinical trials and complex biotechnology-related medicines. The company is experienced in over 450 products, including rDNA proteins and peptides, vaccines, gene and cell therapy, tissue-engineered products and innovative new chemical entities. ERA can assist with product development from preclinical and chemistry, manufacturing and control (CMC), through to support with clinical trial design and applications, agency interactions (EU, US and Australia), and complete eCTD-based submissions to regulators.