How does the customer benefit?
First the company’s cGMP / FDA readiness status is assessed accurately and comprehensively. Then, taking into account the know-how and special situation of the company, we produce a scalable remediation project plan with a cost estimate ±20% as decision base for the management. Based on the subsequent decision, the project is tailored and performed to the management’s expectations. This way cGMP / FDA readiness is achieved in high quality and at minimal cost – especially compared to the often seen poorly led and coordinated cGMP / FDA remediation projects.
Case 1:
A leading global pharmaceutical company decided to achieve a step change in cGMP / FDA readiness. After preparing and leading the kick-off meeting of the project (80 FTE, 2 days), we elaborated the project plan and cost estimate, then coordinated the project with 80 internal part time experts over 2 years and led 2 of the 17 project teams. Within this project numerous substantial cGMP concepts were elaborated and some of them rolled out into the whole corporation worldwide. Later many of those concepts were successfully audited by FDA.
Case 2:
A global big pharmaceutical company registered a product in the USA, but had no FDA experience at the bulk and FDF production site. MVLSC analyzed the site, elaborated together with the local team a remediation plan in a work shop, produced the cost estimate, scaled the project plan down to the level approved by the management, helped to recruit additional temporary experts and led the project for 1.5 years (60 internal part time experts, 8 external FTE experts). The audit was successful with no major 483 observations.
Case 3:
A mid-sized global pharmaceutical FDF company wanted to assess their ability to enter the US market. MVLSC analyzed the company, produced a remediation action list in a workshop with the company’s experts (1.5 days, 30 experts), then elaborated a remediation plan and cost estimate. Based on this the company developed the strategic plan for change. Additionally the local authority announced an audit short term. MVLSC led the preparation of the audit based on the down-scaled FDA readiness project plan. The audit was very successful (no major observations).
