Overview of Services

ERA specialises in regulatory affairs consulting services relating to biotech and biological products, and has focused on this field for over 20 years. We have assisted clients from Europe, the United States, Australia, Japan, and other regions to achieve efficient and expedient marketing authorisation for their innovative products. During the past 20 years, we have dealt with over 500 such products in one way or another, our input ranging from feasibility studies or advice on regulatory strategy, to the compilation and submission of complete dossiers. This extensive experience, with our proven track record, 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, gene therapy and viable cell products, including engineered tissues. Many of the products concerned were at the "cutting edge" of science and required appropriately innovative regulatory strategies. Some of these were products in early development, other activities were at the submission stage, and we were also involved 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. It is worth mentioning at this point that our clients are provided with access to our extensive database of these regulations. However, these are but one of the foundation stones for our work. 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 biotech and biological medicinal products in general.