ERA can provide useful regulatory affairs advice at all stages of product development, from the early concept stage, through product development, up to and beyond submission of a dossier for marketing authorisation. We recommend that regulatory input should be initiated early on, but we can usually help at any stage of project development. ERA can provide strategic guidance as well as practical feedback. Our input may highlight a new regulatory avenue, leading to a more efficient development plan.

With our extensive practical experience in regulatory affairs, the ERA team understands and can interpret regulatory scenarios for clients. In cases of precedence, we can provide help in seeking the advice or opinion of regulators. Input during the pre-submission phase of a project can prove to be vital; strategies for interacting with regulatory agencies contribute towards achieving consensus at pre-submission meetings.

Areas covered by ERA's regulatory affairs consulting include:

Project management input

Regulatory affairs input

Technical-regulatory advice

Examples of agency interactions