Era Consulting (Australia) Pty Ltd

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About Era Consulting (Australia) Pty Ltd in Toowong

The objectives of the Australian office will be as follows: Making our expertise in regulatory affairs available to the local biopharmaceutical industry, in order that products under development in Australia will meet international requirements, hence adding value to our clients projects. Providing our services and capabilities in the western Pacific Rim region in general, covering not only Australia, but also the important emerging markets in Southeast Asia. Extending our services for clients in Europe and North America, to cover clinical phase development and submissions in Australia, New Zealand and other countries in the region. Expanding our overall capabilities for expedient project work, offering round-the-clock work in the ERA Consulting organisation. The ERA Consulting Group is one of the longest established and most experienced consulting groups serving the biopharmaceutical industry.

Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development strategy and regulatory requirements. Biopharmaceutical products and biomarkers are our particular speciality. ERA has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond. Our expertise covers a wide range of products (around 400 products to date), including products of recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products comprising gene therapy, somatic cell therapy and tissue-engineered products.

ERA is also competent to consult on innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases. Last, but not least, the ERA team includes specialists for companion diagnostics and biomarkers, offering dedicated services in this cutting edge field.

Keywords: Business Management Consultant, Feasibility Study, Auditing, Consultants, Product Development, Due Diligence, Regulatory Affairs, Product Licensing, Biopharmaceutical, Biopharmaceutical Products, Biotech Products, Development of a Regulatory Strategy, Development Strategy, Manufacturing Strategy Advice, Product Development Consulting, Regulatory Affairs Advice, Regulatory Affairs Consulting Services, Regulatory Strategy, Technical-Regulatory Advice
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