London Gas Museum, Twelvetrees Crescent
London E3 3JH
United Kingdom
Phone: +44 20 7510 0200
Fax: +44 20 7510 0218
Description:
The ERA Consulting Group specialises in regulatory affairs consulting services relating to biotechnology and biological medicinal products. Currently, we have offices in the UK (London), the US (Washington D.C.), Germany (near Hanover) and Australia (Brisbane). We have experience with over 250 products with our input ranging from feasibility studies and advice on regulatory strategy, to the compilation and submission of complete dossiers. Our clients range from virtual biotech start-up companies to the largest multi-national pharmaceutical corporations. Our proven track record of 20 years places us in an unrivalled position as consultants in this specialised field and provides a level of expertise from which all clients can benefit.
The types of products on which we have consulted include “natural” biologics, for example blood products and plant derivatives, but the majority of projects have been related to recombinant proteins, monoclonal antibodies, gene therapy and viable cell products, including engineered tissues. Many of the products concerned are at the “cutting edge” of science and required appropriately innovative regulatory strategies, from early development, through the submission stage, and also in supporting clients during the response phase to health authority questions and objections.
Needless to say, ERA has thorough knowledge and understanding of the relevant directives and guidelines that have been issued by ICH, the European, US and other authorities. However, ERA’s approach has always been interdisciplinary, with a strong emphasis on the science underlying the product. Accordingly, our scientists have backgrounds that are relevant and important for our consulting work, including molecular and cell biology, protein biochemistry, immunology, manufacturing and control, pharmacology and quality assurance. An advantage for the client is that our scientists require a minimum of introduction and education with respect to the subject matter of new products, since they already bring broad knowledge to the table on biotechnology and biological medicinal products in general.
In addition to our consulting activities, ERA Consulting offers a number of supporting services. An example is our European Regulatory Intelligence service (ERi), which is a website based subscription service designed to keep professionals totally up to date with the continually evolving European regulatory arena. ERA also offers training and educational courses in a wide variety of subjects relating to biotech drug development through our “intERActions” service.