Product Compliance: Business Analyst
Solution

Endeavor stepped in to provide a Business Analyst Specialist. Their goal was to consolidate pedigree information — specific to the manufacturing and distribution of products — that falls under the Federal Mandate. This Mandate requires all handlers (Distribution Centers and other) who distribute the products to be appropriately licensed, across all states.

Benefit

By consolidating all of the pedigree information within a single database — a database specific to the manufacturing and distribution of products — Endeavor was able to streamline the client’s process and ensure nationwide compliance.

 

Endeavor’s Business Analyst also developed a new internal business process and review mechanism, which ensured that all product handlers distributing the products were appropriately licensed in every state.

 

Overall, this project allowed the client to achieve major cost savings, and to complete the project on budget and on schedule.

Problem

A global pharmaceutical client had no centralized repository system to manage the various licenses required to distribute their products across the U.S.

 

This growing organization needed to ensure full compliance to all U.S. state licensure and registration, as well as plan for future federal regulations. This included the vital step of giving all distribution centers access to the appropriate licenses, across all states.

 

In order to address this gap, the client developed a new U.S. licensure COE (Center of Excellence) responsible for leading processes and systems to assure all business (Manufacturing, Marketing & Distribution) organizations complied with all required licenses and registrations.

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