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Pharmaceutical packaging dossiers

Dossier packages for seamless integration into drug applications
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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.

World map with countries of the pharmaceutical packaging dossier highlighted in blue

All information in a single, complete dossier

Our packaging dossiers are prepared for your specific containment system combination. As such, these packages include relevant compliance documentation for all aspects of pharmaceutical containment systems and their related components.
REQUEST PACKAGING 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.

Request customized documents

SCHOTT Pharma offers support in all aspects of your registration approach. Please send us your request using the link below.

Customized document by SCHOTT Pharma

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.

Get in touch

Dr. Frank Hoffmann-Geim

Dr. Frank Hoffmann-Geim

Director Regulatory Affairs

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