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Switzerland · Specialty pharmaceutical manufacturer

Cross-border data posture for a manufacturer in three regimes.

A specialty pharmaceutical manufacturer operating across three regulatory regimes asked us to help the firm think clearly about a question its compliance team had been holding alone — whether the firm’s data architecture, taken in the round, was something the senior team could speak to with one voice.

The work was less technical than it appeared. The firm did not need a new data platform; it needed a posture, written down once, that the firm could carry into any of the three regulators’ rooms without contradiction.

The engagement closed once the senior team could articulate the posture without reference to our memos.

Regulatory posture is operating posture, with paperwork.

What we did

  • Reconciled the firm's data architecture against three overlapping regulatory regimes.
  • Designed a single internal posture the firm could explain in any of the three regulators' rooms.
  • Sequenced the technology programme behind the posture, not in front of it.
  • Stood up an internal council with the authority to maintain the posture after the engagement.

Practice · Technology

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