Interim QA and compliance directors, remediation program leaders, and validation project managers. These are people who have led this kind of work before and can take charge in the first week.
Someone to run the quality or compliance function while you hire, reorganize, or grow.
Running a remediation program so the commitments made to FDA are met on time.
Running validation projects that involve quality, IT, and operations.
Knowing which validation steps depend on which, and getting QA, IT, and operations to move in the right order.
A good general project manager can keep a schedule. In a GxP program, they also need to know what happens when a date promised to the FDA slips, and how to keep that from happening.
A drug manufacturer has received a warning letter and committed to a remediation schedule. It needs a compliance lead and a CSV specialist to meet those dates.
A pharma company is partway through an ERP upgrade and does not have enough people to keep up with IQ/OQ/PQ and change control.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
A program with agreed scope and milestones, reporting to your leadership.
An interim quality, compliance, or validation leader working inside your organization.
Share your situation and the systems involved, and we will outline how we would approach it.