Solutions

Our customized solutions are improving project outcomes for some of the biggest companies in the pharmaceutical industry

Regulatory Case Study

Streamlined Pharmaceutical Drug Submission

Challenge

A large pharmaceutical company was working toward the submission of a new drug application for a major new cardiovascular drug. An already tight schedule needed to be reduced by 5 weeks to meet the target submission date.

Solution

A Pentico consultant established master milestones for the campaign, developed and maintained the project schedule, and created detailed work plans for the skill centers which provided critical resources to the final phase of the submission. Pentico facilitated project team meetings, organized meetings for the critical skill centers, and provided weekly status reports and plan updates.

Results

The new drug application was submitted to the FDA 3 days ahead of the target date. The drug was approved by the FDA and market share has been growing rapidly since approval.