Some of the hardest quality work is a project with a deadline, not a finding. We project-manage manufacturing transfers, site startups, commercialization, field actions, and response programs for the U.S. Food and Drug Administration (FDA).
A transfer succeeds when specifications, process knowledge, and acceptance criteria all arrive intact and the receiving site builds what the design intended. A field action succeeds when the right people move in the right order, with records that hold up afterward.
We bring a plan, a schedule, an owner for each task, and regular reporting against all three. When something slips, you hear about it from us first.
If you have never run one of these before, that is fine. Many clients have not, and the cost of learning on the job is high.
When to call us
- “We are moving a product line to a new plant on a fixed date.”
- “A field action across three product lines, and we have never run one.”