ERA Consulting - Specialist Consultants to the Biopharmaceutical Industry
Biotech product development and regulation is a potential maze with countless pitfalls and conflicting signals, well represented by the confusing 'traffic light tree' shown on the left, which happens to be situated close to the European Medicines Agency in London. With our experience and expertise, the ERA team can help develop and implement a clear development and regulatory pathway for the most innovative and complex biotech products.
Regulatory Affairs and Product Development Consulting
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.
Our specialised international team of more than 30 professionals includes scientists with a research and development background, those with extensive industry experience and former regulators, offering both breadth and depth of expertise, from which our clients can benefit.
ERA has sophisticated and well-equipped office facilities, currently in four locations (Germany, the UK, the USA and Australia), with the in-house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group.
Please use our 'contact us' form for any further information you may require. The ERA team would value the opportunity to present our capabilities and expertise in a personal meeting.
What's New at ERA?
ERA is pleased to announce the launch of our dedicated Biomarker Division to support your development and regulatory affairs needs in this exciting field. Recognising the role and potential of biomarkers in the drug development arena, both the European regulatory authorities and the US FDA have markedly increased their visibility and activity in this space. There is clear indication, with new guidelines and procedures in place, that regulatory agencies are ready to work with those companies developing them. Our Biomarker Group, backed up by the input of other scientific disciplines in the ERA team, has the experience and knowledge to add substantial value to clients' projects in this field.