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TECH-TRANSFER-AS-A-SERVICE

The only constant is change. There are many reasons to switch manufacturers during the life cycle of a product. With our support, you can play it safe.

There are many different reasons for changing the contract manufacturer of a product. Most transfer projects have one thing in common, though: at some point, a certain amount of time pressure is involved, and sometimes there is even the threat of inability to deliver.

To prevent this situation from overwhelming your team and weakening your core business, we take over the coordination. Our experts from various disciplines work hand-in-hand to master this challenge and take care of...

...planning and implementation:

Starting with the selection of a contract manufacturer, we also take care of negotiations, contract design and long-term support.

...the qualification of the new manufacturer

We carry out audits and provide support in concluding the delimitation of responsibility agreement, working closely with your quality organization.

...project management:

We’ve not only got the careful planning of budget and timeline covered: our services also include the identification of critical steps, implementation, and professional reporting.

...the support of the transfer:

Specification, validation plan, manufacturing instructions – we review all documents of the new manufacturer according to GMP guidelines, the applicable regulation, and the internal requirements of your QMS.

...risk assessments:

Whether according to ICH Q3D or formation of nitrosamines – the circumstances at your new manufacturer may require an update or the creation of a new risk . Our team supports you with everything that’s necessary.

...deficiency letters:

Receiving a deficiency letter from regulatory authorities during the technology transfer can be a significant obstacle. We provide scientific expertise to address any concerns raised by the authorities, ensuring that your documentation and data meet the required standards. Whether it's clarifying technical details, updating risk assessments, or providing additional scientific justification, we work closely with you to resolve any issues efficiently.

...regulatory support:

We define the documents to be submitted and prepare the dossier. We are also happy to take on the submission and procedural support of change notifications.

...trouble shooting:

Even with the best planning, unforeseen situations can occur. Last but not least, our team provides hands-on support for validation runs and the assessment of new impurities.

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to get a smooth and efficient transition started.

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