What is it about ?
During the preparation for product or service launch, Avanti Europe experts support with hands-on expertise in validating the product, compiling the submission documentation and negotiating to get market approval.
What we offer:
With Avanti Europe as your partner, we will take care of the launch preparation. Either as your project manager or as a member of your team, our consultants and contractors help validate the product or service and prepare the regulatory documentation, such as technical file (TF), common technial documentation (CTD), novel food application and cosmetics notification.
Based on the development and source documentation, we can support as a hands-on workforce in:
Copile Validation Master Plan
Conduct product validation studies
Conduct Medical Device validation studies
Author validation reports
Author submission/notification documentation
Support in authority questions and discussions
HOW we do it:
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Based on the development and source documents, we can support in validating the product. With these results, a compilation of the notfication or submission dossier is possible.
With a simple 3-step approach, Avanti Europe experts validate the product, compile the necessary regulatory documentation and submit the documentation in the name of the client to the respective authority.
During the launch support, different tasks have to be fulfilled, depending on the product certification. These tasks are to be fulfilled in a close cooperation and coordinated with the launch manager, manufacturing, regulatory affairs and logistics. Not seldom, launches are timed in such a way as that the next day after receiving market approval, sales can start.
For the launch preparation, there is no room for delay or error and the departments need to be orchestrated diligently to hit the target date.
why we are the right choice:
Avanti Europe has a proven track record of launch preparation. With this, its experts maintain also a large and personal network and can assess complex regulatory strategies and challenges fastly and holistically.
