Metadata Manager

Overview #

The Metadata Manager in DnXT Administrator is the central repository for all reference data that describes your regulatory portfolio — companies, contacts, products, substances, manufacturers, excipients, indications, dossier types, and submission types. This structured metadata is used throughout DnXT Publisher, Reviewer, and Planner to populate dropdown menus, auto-fill submission fields, and ensure data consistency across dossiers.

By maintaining a single source of truth for organizational metadata, you eliminate data entry errors, enforce naming conventions, and ensure that submissions reference standardized vocabulary.

Why Metadata Matters: When a user creates a new dossier or submission in Publisher, they select the Company, Product, Dossier Type, and Submission Type from dropdowns populated by the Metadata Manager. Accurate, up-to-date metadata saves time and prevents inconsistencies that could cause regulatory filing issues.

Accessing Metadata Manager #

Log in to DnXT Administrator.
Click Metadata Manager in the left sidebar.
The Metadata Manager view opens with multiple tabs, one for each entity type.

Common Interface Pattern #

All Metadata Manager tabs follow a consistent pattern:

Data Table — A list of all records of that entity type, with sortable columns
Toolbar — Action buttons: Add, Delete, Export, Refresh
Detail Panel — Opens when you click a record, showing editable fields

Adding a Record #

Click the Add button in the toolbar.
Fill in the required fields in the dialog or detail panel.
Click Save.

Editing a Record #

Click a record in the table to open its detail panel.
Modify the desired fields.
Click Save.

Deleting a Record #

Select one or more records in the table (click to select, Ctrl+click for multiple).
Click the Delete button in the toolbar.
Confirm the deletion in the dialog.

Warning: Deleting a metadata record may affect existing dossiers, submissions, or other entities that reference it. Before deleting, verify that the record is not in use. Consider deactivating or archiving unused records rather than deleting them.

Entity Types #

Company #

The Company tab manages the list of companies (applicants, sponsors, marketing authorization holders) that appear in dossier and submission metadata.

Company Fields #

Field	Description
Company Name	The full legal name of the company
Applicant ID	The regulatory applicant identifier (e.g., DUNS number or regulatory authority ID)
Contact Association	Link contacts to the company using a dual-list selector

Associating Contacts with a Company #

Select a company from the table.
In the detail panel, find the Contact Association section.
The section displays two lists: Available Contacts (left) and Associated Contacts (right).
Select contacts from the Available list and use the arrow buttons to move them to the Associated list.
Click Save.

Contact #

The Contact tab manages individual contact records — people associated with companies, regulatory authorities, or your organization.

Contact Fields #

Field	Description
Name	Full name of the contact
Type	Contact type (e.g., Regulatory Agent, Medical Contact, Legal Contact)
Phone Numbers	Multiple phone numbers with type dropdown (Office, Mobile, Fax, etc.)
Email Addresses	Multiple email addresses

The contact form supports adding multiple phone numbers and email addresses. Click the + button next to the phone or email section to add additional entries. Each phone number has a type dropdown (Office, Mobile, Fax, Home) for categorization.

Product Family #

The Product Family tab groups related products under a single family. This is useful when your organization has multiple product strengths, formulations, or regional variants that belong to the same product line.

Product Family Fields #

Name — The product family name (e.g., “Productol”)
Description — An optional description of the product family

Product #

The Product tab is one of the most detailed entity types. It manages individual pharmaceutical products with their full characteristics and regulatory relationships.

Product Fields #

Field	Description
Product Name	The trade or proprietary name of the product
Description	A brief description of the product
Dosage Form	The pharmaceutical dosage form (e.g., tablet, capsule, injection, cream)
Manufacturer	The primary manufacturer (selected from the Manufacturers list)
Product Code	An internal or regulatory product code

Product Strengths #

Each product can have multiple product strengths (e.g., “10mg”, “25mg”, “50mg”). Strengths are managed through an inline table within the product detail panel:

In the Product detail panel, locate the Product Strengths section.
Click Add to create a new strength entry.
Enter the strength value (e.g., “10 mg/mL”).
Click Save.
Repeat for additional strengths.
To remove a strength, select it and click Delete.

Product Relationships #

Products can be linked to multiple related entities. The product detail panel includes relationship sections for:

Substances — Active pharmaceutical ingredients (APIs) in the product
Manufacturers — All manufacturers involved in the product (may differ from the primary manufacturer)
Excipients — Inactive ingredients used in the formulation
Indications — Therapeutic indications for which the product is intended

Each relationship section uses a list interface where you can add or remove associations.

Tip: Before setting up product relationships, ensure that the related entities (Substances, Manufacturers, Excipients, Indications) have already been created in their respective tabs. You can only associate a product with entities that already exist in the system.

Substance #

The Substance tab manages active pharmaceutical ingredients (APIs) and other substances referenced in submissions.

Name — The substance name (INN, USAN, or other standard nomenclature)
Description — An optional description

Manufacturer #

The Manufacturer tab manages manufacturing sites and organizations involved in producing pharmaceutical products.

Name — The manufacturer’s full legal name
Description — An optional description (e.g., site location, manufacturing capabilities)

Excipient #

The Excipient tab manages inactive ingredients used in pharmaceutical formulations.

Name — The excipient name (per pharmacopoeial standards)
Description — An optional description

Indication #

The Indication tab manages therapeutic indications — the medical conditions or diseases for which products are intended.

Name — The indication name (e.g., “Type 2 Diabetes Mellitus”)
Description — An optional description

Dossier Type #

The Dossier Type tab defines the types of regulatory dossiers your organization manages. Dossier types correspond to the regulatory application categories used by health authorities.

Name — The dossier type name (e.g., “NDA”, “BLA”, “MAA”, “ANDA”)
Description — A description of the dossier type

Submission Type #

The Submission Type tab defines the types of submissions that can be created within a dossier. Submission types correspond to the sequence types defined by regulatory authorities.

Name — The submission type name (e.g., “Initial Application”, “Amendment”, “Supplement”, “Annual Report”)
Description — A description of the submission type

Dynamic Tabs #

In addition to the standard entity tabs, the Metadata Manager may display dynamic tabs for custom entity types defined through the Object Manager. These tabs follow the same pattern as the built-in tabs (data table, toolbar, detail panel) but display fields defined by the custom object type schema.

Exporting Metadata #

Each entity type table supports CSV export:

Navigate to the desired entity tab.
Click the Export button in the toolbar.
A CSV file downloads containing all records for that entity type.

Tip: Regularly export your metadata as a backup and for documentation purposes. The CSV exports can also serve as input for data review processes or for populating other systems.

Best Practices for Metadata Management #

Establish Naming Conventions #

Define and document naming standards for all entity types. For example, decide whether to use brand names or INN names for substances, and whether company names should include legal suffixes (Inc., Ltd., GmbH).

Keep Metadata Current #

Assign a data steward responsible for periodically reviewing and updating metadata. Outdated records (e.g., products no longer in development, companies that have been acquired) should be clearly marked or removed.

Populate Before Onboarding Users #

Set up your metadata (especially Companies, Products, Dossier Types, and Submission Types) before inviting users to start creating dossiers. This ensures a smooth onboarding experience with all dropdown options available from day one.

Use Relationships Consistently #

When creating products, always populate the relationships (substances, manufacturers, excipients, indications). These relationships enable powerful cross-referencing and reporting capabilities.

FAQ #

Can I import metadata in bulk? #

DnXT does not currently support bulk import through the Metadata Manager UI. Records must be created individually. For large-scale data migration, contact DnXT Solutions support to discuss batch import options.

What happens if I rename a metadata record? #

Renaming a record updates the display name everywhere it is referenced (dossiers, submissions, dropdowns). The internal record ID does not change, so existing associations are preserved.

Can different tenants have different metadata? #

Yes. Each tenant has its own independent set of metadata records. A product defined in Tenant A does not appear in Tenant B’s dropdowns.

Are there limits on the number of metadata records? #

There are no hard limits on the number of records per entity type. However, very large lists (thousands of entries) may take longer to load in dropdown menus. Consider using hierarchical organization (Product Families) to manage large product catalogs.

Can I create custom entity types beyond the built-in tabs? #

Yes. Use the Object Manager to define custom object types with custom fields. These will appear as additional dynamic tabs in the Metadata Manager. See Object and Attribute Management for details.