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Pharma regulatory services

Complete support for the integration of primary pharmaceutical packaging content into drug and medical device registrations
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Supporting seamless integration into pharma registrations

Regulatory services help drug product or medical device owners make information about containment systems available for registration. SCHOTT Pharma ensures the global regulatory availability of its containment solutions in compliance with evolving international norms and standards, as well as country-specific laws and guidelines. Different countries follow different registration processes:

  • In countries following Drug Master File (DMF) or national product registration approaches, pharmaceutical packaging is registered separately from the drug product or medical device by SCHOTT Pharma.

  • In many other regions, such as the EU, South America, and Australia, the pharmaceutical packaging documentation must be submitted by the drug product or medical device owner as part of the application dossier.

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Check regulatory availability

Are you planning to register your drug or medical device product and would like to check current availability? SCHOTT Pharma can provide a summary of the regulatory availability specific to your product and countries of interest.

Check the regulatory availability of your product here

Expert knowledge and global reach

To help make your product available in your target countries, SCHOTT Pharma has an expert team and global network to enable the regulatory availability of our containment solutions across the world. To simplify the integration of containment solution content, we follow three key principles:

  1. We talk the language of pharma.
  2. We work with pharma industry dossiers in standard formats, such as eCTD.
  3. We constantly monitor the evolving regulations for pharmaceutical packaging.

Global coverage - Our expert network and processes support your registrations worldwide, applying standard pharma industry dossier formats suitable for each country.

Reliable partner - Our best practices and proven track record ensure that dossiers match authority perspectives.

Always up-to-date - We constantly monitor regulatory changes and assess the impact on registration requirements.

Direct contact - Our regulatory expert team is always on your side in the event of urgent authority enquiries.

Dr. Arne Kloke, SCHOTT Head of Service and Sustainability Management
Dr. Arne Kloke, Head of Service and Sustainability Management
When urgent FDA inquiries threaten to interrupt client manufacturing schedules, the SCHOTT team is immediately at their side with their expertise to resolve the issue.

Pharma regulatory services: How to proceed

The SCHOTT Pharma team of specialists is available to offer support and advice about your pharmaceutical packaging challenge. We offer a complete process for regulatory services to take you from initial request to effective solution.

1. Share registration plans

Please use our online check for regulatory availability as early as possible in your registration project to ensure alignment on the intended countries and timelines.

2. Receive status report on regulatory availability

For your product and countries of interest, the status report will keep you informed on the status of current registrations and how coverage can be extended if required.

3. Completion of regulatory coverage

Based on an aligned proposal and project plan, we’ll prepare the open DMF or NPR registrations, or customized dossiers to support your full regulatory coverage.

4. Authority support

If an authority enquires about your applications, you have direct access to our experts to respond quickly and resolve open issues.

Get in touch

Dr. Frank Hoffmann-Geim

Dr. Frank Hoffmann-Geim

Director Regulatory Affairs

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