Packaging dossiers from SCHOTT Pharma
In many regions, such as the EU (under EMA), South America, and Australia, the packaging information must be submitted as an integral part of the drug application dossier itself. In these countries, the regulations do not allow for separate registration of the containment system.
To simplify documentation of containment-related aspects, we offer customized, article-specific documentation packages in eCTD format, which ensures seamless integration into the final drug application dossier. If additional documentation is needed, our regulatory team can generate customized documents.
Pre-compiled packaging dossiers for faster submission
On customer request, our regulatory expert team can prepare pharmaceutical packaging dossier packages specific to the article-specific combination in conformity with the latest standards and health authority requirements. These packages contain the required compliance documentation. Customers also have the option to include the text chapters that describe the pharmaceutical packaging in the drug application dossier.
By following the predefined dossier structure and eCTD submission format, these packages can be seamlessly integrated into the final drug application dossier. For customers, this removes the burden of screening multiple sources for completion of document collection. When the packages are extended with established chapter formulations, customers benefit from faster submission of descriptions that have already proven to be compatible with authority expectations.
All information in a single, complete dossier
Packaging dossiers: How to proceed
Packaging dossiers are specific to your combination of product and country of interest. SCHOTT Pharma’s experts are ready to compile those documentation packages for you, at your request.