ERA Consulting Information

ABOUT US The ERA Consulting Group offers consulting services and strategic advice in regulatory affairs and product development, specialising in prescription biopharmaceutical products and biomarkers. Over the last 24 years ERA Consulting has evolved into a leading organisation that has successfully aided the advancement of more than 400 medicinal products. Our strength, quite apart from regulatory expertise, is our strong scientific focus (15 PhDs) with a profound understanding of product development issues. OUR CLIENTS At any one time, ERA is working with 5 of the top 10 pharmaceutical companies. However, ERA also works with a large number of small-to-medium sized enterprises/start-ups to assist with their innovative products. OUR EXPERIENCE - Biosimilars - Recombinant proteins - Antibodies - Vaccines - Gene therapies - Cell products including engineered tissues and stem cells - Blood products and plant derivatives - NCEs OUR SERVICES - Clinical trial applications in Europe, the USA and Australia - Advice on requirements for validation and control of biological manufacturing process - Data package assessments/gap analysis to identify possible deficiencies in preparation for audits or deal negotiations - Develop/reinforce a product's regulatory pathway for use during investment/licensing negotiations - Technical writing including preparation of expert reports, summaries, complete dossier compilation - Support with Agency meetings in Europe, Australia and the USA