Strategic advisory for projects that span several disciplines

Large projects combine several disciplines. Each card leads to a path with its stages in the order in which they are needed.

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The projects

Your manufacturing is changing site, scale or supplier: how does the marketing authorization stay valid?
When a process moves to another site or to a larger scale, transfer, supplier qualification, validation, variation and batch release interlock.
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Your product needs CE certification under MDR or IVDR: which stages lie ahead?
On the way to the notified body certificate and beyond it, classification, technical documentation, clinical evidence, QMS and post-market surveillance interlock.
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You are building a GMP plant or a new production line: which stages lead up to the first inspection?
For a new plant or a new line, investment planning, qualification, contamination control, validation and inspection preparation build on each other.
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Your quality system is being built from scratch or has to bring several sites together: how does it become ready for inspection and notified body audit?
Whether a quality system is new or grows from several sites: baseline, document structure, deviations, data integrity, inspection preparation and CAPA depend on each other.
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You are restructuring your supply chain and contract manufacturers (CDMOs): in which order does supply stay secure?
When contract manufacturers, suppliers or distribution partners are chosen anew, mapping, tendering, qualification, distribution and the management of supply are tied to one another.
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Your GxP systems are growing, going digital or using AI: how does the validated state stay provable?
If you introduce systems, replace paper or bring AI into GxP processes, plan inventory, validation, data integrity and AI classification together.
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Briefly outline your industry, topic and timeline. We'll respond with an initial assessment, usually within one business day.

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Strategic advisory for projects that span several disciplines

The projects

Your manufacturing is changing site, scale or supplier: how does the marketing authorization stay valid?

Your product needs CE certification under MDR or IVDR: which stages lie ahead?

You are building a GMP plant or a new production line: which stages lead up to the first inspection?

Your quality system is being built from scratch or has to bring several sites together: how does it become ready for inspection and notified body audit?

You are restructuring your supply chain and contract manufacturers (CDMOs): in which order does supply stay secure?

Your GxP systems are growing, going digital or using AI: how does the validated state stay provable?

Let's talk about your project.