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Our client’s Regulatory Affairs Group needed to establish a standardized tracking system to identify when their regions update local labeling/prescribing information. To move from the current manual process to an automated process, our client needed to implement and tailor an off-the-shelf “Global Decision Tracking Portal.” The Regulatory Affairs Group with approximately 700 end users and professionals, establishes credibility with regulatory agencies, successful product registrations, and compliance worldwide based upon new regulatory requirements.
Our consulting team provided the following core project activities:
Our solution provided:
We successfully moved our client’s standardized tracking system from a manual to automatic process. This project was completed on time and within budget.