Post-Approval

It should be apparent that the ERA team can support a client’s efforts from early stage development of a biopharmaceutical product, through the entire regulatory process to a successful marketing authorisation. However, our services do not necessarily stop at that point. Once approval has been obtained, there is usually a need for variations on the original marketing authorisation, introducing process scale-up, changing details in the product characteristics, adding new dosage strengths of the product, or new presentations, introducing new manufacturing facilities, applying for additional indications, and so forth. Moreover, a marketing authorisation requires continuous monitoring, in order to ensure that the conditions of the approval are being met, for example in the area of responding to ongoing questions that were not answered pre-approval. In some cases, we have continued to work on products that were originally approved with our involvement more than 18 years ago. In such cases, ERA provides continuity in understanding how the product and the process has evolved over that period of time, providing input on the strategy and timing of future variations, and supporting the client in obtaining agreement with the relevant regulatory authorities on the strategy for changes.

Our services relating to post-approval issues include: