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Simplify the creation of package inserts.

Create and manage all your package inserts for medical devices in XML with a single tool.A tool that lets you easily edit, convert, proofread, and share package inserts in the cloud.

PackinStarMD

Create, Manage, and More— with our all-in-one solution.

Cloud Tool

Cloud Tool

No installation required. Sharing and handover are easy.

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Editor

Edit

Easily edit complex tables and lists. Real-time preview and enhanced error checking.

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Convert

Convert

Standard equipment for PMDA-compliant XML conversion. Easily convert to PMDA-ready PDF and Word formats.

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Administrator

Management

Effortless document management. Track version history and compare differences.

Learn about management methods
Proofreading

Proofreading and Workflow

Build a smooth workflow for proofreading tasks on the web.

Learn about proofreading methods
Proofreading

Support

Our experienced staff provide comprehensive support for any challenges or technical issues in creating package inserts.

Learn about support

Introducing PackinStarMD

Ready to Use Immediately

No Installation Required

Since it’s a cloud tool you can access through your web browser, there’s no tedious installation required.With all work stored in the cloud, collaborating, sharing, and handing over tasks among team members is effortless.

Cloud Tool
No software installation is required on individual PCs; you can start immediately using a web browser.
Team Collaboration
Share work progress and data within your team. Ensure smooth handoffs for tasks.
Secure Authentication
Access cloud data securely using authentication provided by major cloud services.
Reliable Backup
Data created by your company is stored in a cloud database. The database is redundant, and backups are solid and reliable.
Edit Panel

Simple Editor

Just Fill in the Templates

Simply fill in the header templates following the PMDA-compliant package inserts for medical devices in XML.Anyone can quickly create XML or PDF package inserts.

PMDA-compliant XML Import
You can import XML converted from old SGML using the PMDA tool.
Heading Template
Simply fill in the prepared headings with your content.
Preview
You can preview your content as it will appear on the actual PMDA site.
Error Checking
Displays error messages that clearly indicate the next steps required.
Generic Name / Adverse Event Terminology Search
Easily search medical device–specific generic names and adverse event terms to quickly find exactly what you need
Simultaneous PDF Creation
PDFs can be created simultaneously, allowing you to check them at any time during editing.
Edit Panel

Supporting Editing Work

Effortless Batch Processing

All you need to do is fill in the heading templates based on the PMDA-compliant XML format.Anyone can quickly create package insert XML or PDF files.

Batch Revision Marking Feature
Easily reassign the current revision marks in bulk as the previous revision.
Automatic Reference Sorting Feature
Reorders references according to their order of appearance in the document.
Bulk Find & Replace
Search for text within the document. You can also replace all instances of the found text at once.
Edit Panel

One Source, Multiple Outputs

Convert One Edit Data into Multiple Formats

Generate XML, PDF, and Word files from a single data source.You can also switch templates to produce outputs with different layouts.

XML Conversion
Generates PMDA-compliant XML package inserts for medical devices.
PDF Output
Generates and outputs PDFs for PMDA submission. Using a template system allows for layouts tailored to your company's format.
Word Output
Generates and outputs Word documents. Can also be used for proofreading tasks.
Multi-Output Conversion

Managed Entirely Within the Tool

Centralized Management in a Cloud Database

Centralized Management in the Cloud
All created documents are centrally managed in a cloud database. Only authorized members of your company can access these documents.
Document Property Check Function
You can check the document's current status, version number, last update date, etc. You can also download XML or PDF files as final approved deliverables.
Version History Feature
Track version history and easily view previous versions.
Difference Comparison Feature
Compare differences in content between older versions or similar products. Comparisons are available in both XML and PDF formats.
Version Management

Proofreading Management and Workflow

Standardize proofreading workflows

Access Control
You can grant document editing and viewing permissions to registered users. Proofreaders can be given view-only access to restrict their operations on documents.
Email Notifications for Proofreading Requests and Results
Proofreading workflows become smoother with email notifications to relevant members, and all communication can be completed within the tool.
Register Comments and Instruction Files
In proofreading tasks, you can share not only approval/rejection results but also comments and files for proofreading instructions.
Proofreading Management and Workflow

Comprehensive Support

Support from Experienced Staff

Expertise in Package Insert Creation
We have extensive experience creating package inserts for medical devices, in vitro diagnostic reagents, and prescription drugs. We leverage our accumulated expertise to support you in solving your challenges.
User-Centric Support System
Our experienced team provides dedicated support, approaching every challenge with professionalism, care, and speed to ensure the best results for you.
Proofreading Management and Workflow

Related Products

Also available: Prescription drugs and IVD

In addition to PackinStarMD, we offer specialized tools for creating package inserts.

All-in-One XML Solution for Medical Device Package Inserts

PackinStarMD

Contact Us

    All-in-One XML Solution for Prescription Drug Package Inserts

    PackinStarXML

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      All-in-One SGML Solution for IVD Package Inserts

      PackinStar

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        Frequently Asked Questions

        What is PackinStarMD?

        It is a cloud tool specialized for creating and managing package inserts for medical devices. You can create and manage PMDA-compliant XML directly from a web browser. It also allows generating PDFs for PMDA publication from a single edit data file.

        It is an all-in-one solution enabling editing, proofreading, and sharing of package inserts for medical devices.

        How do you pronounce PackinStarMD?

        It is pronounced ‘PackinStarMD’ (/ˈpækɪnˌstɑːr ɛm diː/).

        We added 'MD' —short for Medical Device— to our existing PackinStar series of package insert creation and management tools, making it easier to convey that this tool is designed specifically for medical devices.

        What is the difference between PackinStarMD and the PMDA official 'Medical Device Package Insert XML Creation Tool'?

        The main difference is that the PMDA official tool is desktop software requiring installation on individual PCs. PackinStarMD is a cloud-based tool, eliminating the need for such installation.

        Additionally, PackinStarMD includes PDF output functionality and proofreading workflow features. It is designed with the goal of reducing the workload associated with creating package inserts.

        Is it compatible with the PMDA official tool?

        Yes, it is.

        XML created with this tool can be imported into the PMDA official tool to resume editing. You can also import XML created with the PMDA official tool into this tool to begin editing.

        What is the pricing structure?

        It is a subscription-based monthly payment system.

        For details, please inquire via the ‘Contact Us’ form.

        Is installation on a PC required?

        As this is a web-based system, there is no need to install software on individual PCs.

        You can start using it immediately after signing up.

        We are considering implementation. Can we try it out first?

        Yes, that is possible.

        We would like to prepare a trial environment for you after discussing your company's situation. Please contact us via the ‘Contact Us’ form.

        What kind of support can I receive after starting to use this solution?

        Depending on your maintenance contract or subscription plan, our staff may act as a direct point of contact to address technical issues or operational challenges on an individual basis.

        In addition, we provide online documentation including usage guides and FAQs, allowing users to resolve issues on their own if desired.

        On-Behalf Creation

        You can entrust us with the entire process

        We operate the PackinStarMD system on your behalf and handle the creation of package insert XML and PDF documents.When using our document creation outsourcing service, all you need to do is review the content. Once approved, the package inserts can be published immediately.

        Submission

        You can submit your documents in formats such as Word, Excel, or PDF.

        Proofreading

        For any corrections or revisions, our proofreading management system facilitates communication between proofreaders and requesters.

        Publication

        We can also handle provisional submissions to the PMDA website, and any post-publication revisions can be managed by our team.

        Contact Us