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GxP inspection

Your supervisory authority has carried out a GxP inspection at your premises and you do not agree with a deficiency found?

You may need to act quickly. This is because the order requiring you to rectify a defect becomes final after one month. It can then generally no longer be contested. This also applies if the deadline for rectifying the defect is longer than 1 month.

We support you in checking whether the supervisory authority was right to determine the defect.

If the review shows that a challenge to the defect has insufficient prospects of success or that a dispute with the authority about the defect is not worthwhile, we will support you in finding a suitable solution for your company to remedy the defect.

If the review shows that there are good reasons against a deficiency, we will support you in the discussion with the supervisory authority. If this does not lead to anything, we will represent you in any appeal proceedings and, if necessary, in administrative court proceedings.

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