Pharmaceutical packaging dossiers Dossier packages for seamless integration into drug applications
REQUEST DOSSIER PACKAGEPackaging 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
All in one - Get your documentation as a single, complete package, rather than collecting individual parts yourself.
Seamless integration - Integrate the package of text and reference documents directly into the dossier structure and format.
Proven by experience - The contents of packaging dossiers are based on long-term, best-practice global experience of drug and medical device registrations.
Always up-to-date - Document maintenance in eCTD format ensures full change control.
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.
1. Request dossier package
Please use the online form to transfer your product details and other information to receive a proposal including timeline information.
2. Request customized documents
If you want documentation that exceeds the dossier package’s content, please use the online form to receive a proposal, including timeline.
3. Receive dossier package
After proposal acceptance, our expert regulatory team will complete your documentation package via a secured data exchange link.
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