Product Development

During stages of early product development, ERA can offer useful advice on issues of importance for future expedient approval. In our specialised field of biologics and biotech products we inform clients of requirements for manufacturing and control, emphasising the importance of the documenting process as well as product consistency. We have expertise in the design of assays, and can develop statistical models for their evaluation according to pharmacopoeial requirements. Review of production processes and facilities and design of validation protocols are also within our capabilities. In addition, we can produce qualified input for the planning of appropriate stability studies, non-clinical studies and clinical trials. We believe that it is particularly important to receive the benefit of our experience at an early stage, especially where the product under consideration is novel. For products that are being developed initially in the United States, with the intention at a later stage of introducing the product into Europe, e.g. via a marketing partner, it can be valuable to obtain advice on special European requirements that should be taken into account at an early stage, hence avoiding future corrections. In this way, we can add real value to the project.

Examples of our services are: