Member Contact: Dr Daina Vanags
Position: General Manager of ERA AUS & Director of Reg. Affairs for ERA Group
Industry: Industry Support Services
Who and where we are: ERA Consulting (Australia) is a member of ERA Group, a leading independent regulatory affairs and product development consultancy. ERA has a team of highly trained scientists and regulatory specialists, providing independent expert advice to the biopharmaceutical industry for over 25 years. We are global, with offices in Germany, UK, USA and Australia, and are therefore well-positioned to meet client needs in the major markets.
Our expertise: ERA offers strategic scientific and regulatory advice that is specific to the project and based on our extensive experience. To date, ERA has worked with over 450 medicinal products and specialises in biotechnology and biological products, many on the ‘cutting edge’ of science or in the challenging field of global biosimilars. ERA has wide-ranging experience with recombinant proteins and peptides, monoclonal antibodies, vaccines, gene and cell therapies, tissue-engineered products and innovative chemical entities. ERA has also significant expertise in the area of complex drugs, “natural” biologics and combinations with devices. Our consultants have a strong scientific focus and a profound understanding of medicines development processes and regulatory issues, allowing us to identify the most expeditious pathways.
What value we can add: ERA can assist with every aspect of technical development and regulatory requirements, in particular to satisfy EMA, US FDA and Asia-Pacific agencies, using optimal tailored strategies. Our scope of internal expertise covers all preclinical areas: CMC, pharmacology/toxicology, support with clinical trial design and applications, and Agency interactions (EU, US and Australia). ERA can prepare and publish all eCTD-based submissions, for development or full registration programs. We also specialise in due diligence for in- and out-licensing. ERA is committed to maintaining the level of scientific excellence to which our clients are accustomed, providing independent expert advice from early stage product development to clinical trial support and eventual registration of medicines. Our business is to consistently add value to our clients' projects and help them to achieve their goals.
Dr Daina Vanags
General Manager of ERA AUS and Director of Regulatory Affairs for the ERA Group
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