Post merger integration

Pharma industry

Initial situation

A medium-sized company from the pharmaceutical industry was taken over by a multinational pharmaceutical group due to its core competencies in aseptic production and logistics, among other things.

The workforce doubled within 3 months.

The challenge

The inspection by the FDA resulted in a warning letter and remediation was necessary.

The inefficiently structured work processes created an enormous product release backlog by the QPs (Qualified Persons).

The doubling of the workforce caused a lack of space and identification problems.

Objective

FDA approval

Significant reduction of the product release backlog

Prevention of the termination of key employees in the ERP system (SAP) area

Approach

Analysis of processes and optimization according to queueing theory

Workshops with all employees

  • Legal foundations

  • Company philosophy

  • Potential for process improvement

Results

The FDA remediation was successful.

The product release backlog was reduced by 80%.

The dismissal of key employees in the ERP system area was averted.