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Because Products and Processes Change

Approval is just one of many steps in the life cycle of your products. There is still much to do after successful approval: imposed conditions have to be fulfilled, extension deadlines met, periodic safety update reports (PSUR) initiated and submitted on time. On top of this, changes to test methods, packaging materials and packaging texts or the shelf life of the finished pharmaceuticals have to be documented in the CTD and the authorities responsible informed by means of change notifications.

Looking ahead – on your behalf

PhytoLab will support you in updating your approvals and will ease the load on you by reliably tracking your deadlines. We will inform you well in advance about changes to the law and will work with you to plan the steps necessary for securing the marketability of your products for the long term. And should any legal disputes with authorities arise, you can count on our expertise. Our modular range of services gives you a thorough overview of all of the steps we offer. You can take advantage of our full-service package, or commission us for individual work packages.