To provide a smooth process, we obtained a power of attorney (POA). Soon, we were informing the MHRA of our client’s intention to submit an MAA as well as the project deadline. Thanks to our POA, we were able to handle all communications with the agency and respond to any comments, relaying key information to our client. Afterwards, we created a project plan. This plan outlined the overarching strategy and included key details involved in submitting the MAA—such as who was responsible for what activities; when certain actions were required; and which procedures, instructions, and timelines were involved for each module.
We also identified gaps between our client’s documentation and the EU RMP integrated format that would hinder a successful MAA submission—risking rejection of the application and a delay in the initial validation. As we revised our client’s risk management plan (RMP), we discovered areas where the dossier was noncompliant. We knew that—unless we addressed these gaps—our client might experience delays and fail to meet its internal deadline. We acted to correct these disparities quickly. Thanks to Arriello’s expertise, it wasn’t long before an updated and compliant eCTD was in the hands of the UK authorities.