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| The ERA Team During the evolution of our activities over nearly two decades, we have striven continuously to upgrade and update our expertise, reaching a balance in the team between long years of experience and the infusion of know-how in cutting edge technologies. We remain dedicated to the concept of specialising in biopharmaceutical products, in which we have the necessary experience and track record of success. Our team of scientists covers a broad range of disciplines and experience from both research and industry. Each consultant has developed and maintained individual areas of expertise such as gene and cell therapies, peptide products, analytical methods and validation, clinical trial regulation, comparability, virus validation and cell banking. Our scientists are ably supported by our technical and administrative staff, who ensure efficient handling of all aspects of your interaction with ERA. Our Group Director of Regulatory Affairs, Dr. Chris Holloway, has worked on more than 300 different products, providing strategic advice on CMC, non-clinical and clinical development issues in both Europe and the USA. Dr. Dianne Jackson-Matthews, our Deputy Group Director of Regulatory Affairs based in our Brisbane office, has many years of experience in US and European regulatory affairs as well as extensive research and development experience in the production and bioanalytical testing of biotechnology products. In forming a project team we are able to draw together individuals with the appropriate experience either as core members or to contribute to specific aspects as required. In addition, we utilise our network of external experts to ensure that our clients have access to professionals with proven achievement and expertise. To ensure that the needs of each client are anticipated and met, each ERA project is managed by a member of the ERA consulting team, who provides an efficient and responsive interface. |