Professional Service & Consulting
The ERA Consulting Group is one of the longest established and most experienced regulatory affairs and product development consulting groups serving the biopharmaceutical industry.
ERA expertise covers quality, nonclinical and clinical aspects, both from the regulatory and development strategy perspective. ERA has the knowledge and experience to assist from conception to registration, and beyond.
ERA has experience with a wide range of products (over 500 products to date), including recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products comprising gene therapy, gene editing, somatic cell therapy and tissue-engineered products. ERA also works with innovative new chemical entities, particularly those indicated for neurological, oncological and immunological diseases.
ERA specialised international team of more than 24 full-time 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 currently has five office locations (Germany, the UK (2), the USA and Australia), with the in-house capability to prepare documents and complete submissions on behalf of clients, including a dedicated eCTD group.