In order to reach a goal, first one must evaluate their current position. MedXview’s experienced staff can help your team understand your current process, define your goal, and evaluate the changes needed to meet your goals, and do this all faster and with greater efficiency. MedXview remains informed of regulatory requirements through continuous contact with regulatory agencies : FDA, EU, Japan etc.

We have taken part in numerous Pre-submission meetings and can help your team anticipate any changes that may take place to your current business practices to become e-submission ready. Our consultants will provide a Roadmap and Summary sheet. We will evaluate the scope of the guidance and perform comparisons for different regional requirements. We can help centralize and standardize your information, establishing company wide conventions for naming and storage of your data.

Our team will provide a template to map prior e-subs to new granularity (eIND to eCTD, eNDA to eCTD, eBLA to eCTD, CTD to eCTD) and define your LCM (Lifecycle Management) process, enabling your company to establish relationships between documents from Legacy to New. We even provide an evaluation of resources including personnel, and tool comparison and selection.