Patheon’s skilled PDS scientists work closely with our manufacturing groups throughout the development process to ensure their formulations are fully scalable. With development centers located at our commercial manufacturing locations we offer the benefits of a fully integrated development process.

Patheon has extensive experience in the production of registration batches for new customer products. Our support includes the manufacturing of the registration batches as well as with the documentation required for this critical step in the launch of your new product. Patheon provides the following product registration support services.

• Manufacturing, packaging and release testing of registration batches
• Stability study design and monitoring using ICH (International Conference on Harmonization) guidelines
• Documentation provided in submission ready format
  • IND/CTX
  • CMC section of NDA/PL
  • Customized technical reports
• Validation master plan, protocols and reports
• Regulatory guidance from development through to commercialization

Patheon has successfully developed and then launched a number of new products for customers at a number of our sites. As a result, our PAI (Pre-Approval Inspection) team is experienced and well versed in the regulatory requirements of key world markets simplifying your launch process.