USA – Outsourcing in regulatory operations

This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities.

The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that time, regulatory affairs was decentralized and following compartmentalized approaches to health authority (HA) submissions and interactions. Global regulatory affairs (GRA) distributed the needed core documents and an EU-based “Master Dossier” to the local countries and regional operating units (R/OPUs). Local regulatory affairs (LRA) colleagues would then complete the local documentation and submit a dossier based on local HA requirements and standards, which led to a loss in corporate oversight. Submitted quality-relevant documents, as well as approved registrations, were tracked within a corporate regulatory information management (RIM) database, but corporate itself had little insight into the full submission package or any subsequent interactions with the local HA. As a result, corporate was unable to quickly and reliably present what information was submitted to a HA. Additionally, it was discovered that LRAs were modifying documents provided by corporate but doing so without informing GRA. This led to a potentially significant compliance risk for the company.

In early 2015, to address the situation, the author, a team leader in the global regulatory operations (GRO) group, would implement a large-scale, global project to critically map, understand and evaluate the current local compilation process and define and implement appropriate measures to improve quality, transparency and efficiency in a to-be-defined process. The aim of the project was to centralize all technical tasks associated with dossier compilation and submission within outsourced global vendor “hubs” to deliver the expected improvements and minimize the regulatory compliance risk…