You can use an eCTD Compliance binder and connected promotional pieces to generate an FDA Form 2253 from within Vault. Vault automatically populates the form using field values from the binder and from connected documents. With the correct configuration, Vault can generate the supplementary sheet required for multi-product 2253 submissions.

You must use XFA form mapping in order to utilize the FDA’s 2253 form. When you create an eCTD Compliance Package, Vault automatically generates a new Compliance Package with Submission Ready Copies of documents and converts Vault link annotations to relative PDF links.

Preparing to Generate a Package

Before generating a Compliance Package and submitting it to the FDA, you’ll want to verify that your references and promotional materials are in order. “Promotional material” refers to the material you perform the Create Post Marketing Compliance Package or the Create Pre Clearance Compliance Package action on.

On your promotional material:

  • Ensure that any necessary Vault link annotations are on the document versions to be included.
  • Verify that the following fields are populated on all documents:
    • Material Type
    • Professional/Consumer
    • Dissemination/Publication Date
    • Submission Required is set to Yes and that the Submission Type is set to FDA 2253, if applicable
  • Determine which reference documents must be included, and delete any that are unnecessary. For example, if you deleted a Vault link annotation from a document, and the reference document is now unused, you can delete the reference document from the Linked Document section to prevent it from being copied into the Compliance Package.
  • Ensure that the correct version of any relevant supporting documents are included, and delete any that are unnecessary.
  • Upload any additional Clean Version documents in a ZIP file using the eCTD Submission Package rendition type.
  • In the Linked Documents section, verify that the PI labeling material is linked to the correct version of the promotional pieces as linked document or Vault link annotation. Vault copies the PI labeling material to the 1.14.6 Product Labelling section of the package, and any link annotations to the 1.15.2.1.3 Annotated Labeling Version section.
  • Verify that the only documents linked to the promotional material via a Linked Document relationship and/or the eCTD Support Documents relationship are the ones you want copied into the Compliance Package.
  • Ensure that all anchors linking to the promotional piece are in the same version of the reference/PI labeling material. If they aren’t, Vault will not convert some of the anchors to destinations in the binder.
  • On the Dosage and Indication objects, verify that an Admin has created records for the products included in the Compliance Package. This only applies if you are generating a Pre-Clearance Compliance Package.

Adding Supporting Documents

To add supporting documents to the Compliance Package, upload the documents to Vault classified as the Supporting Document type and one of the following subtypes:

  • eCTD Compliance Annotated Material
  • eCTD Compliance Annotated Label
  • eCTD Compliance Annotated Reference
  • eCTD Compliance Clean Material

Then, create an eCTD Support Documents type document relationship between the supporting document and the relevant material included in the bulk action. Vault pulls Supporting Documents into the binder even if Linked References equals No on the Compliance Package.

Vault generates the submission ready versions of supporting documents when you add them to an eCTD Package as follows:

Original Document Subtype Submission Ready Version Document Type eCTD Package Folder
eCTD Compliance Annotated Material Annotated Material Annotated Version
eCTD Compliance Annotated Label Annotated Label Annotated Labeling Version
eCTD Compliance Annotated Reference Annotated Reference Annotated References
eCTD Compliance Clean Material Clean Material Clean Version

Adding Clean Version Documents

You can also add many Clean Version documents to the Compliance Package using a rendition type. Compress the documents into a ZIP file and add them to the promotional material with the eCTD Submission Package rendition type. You can then generate or regenerate the Compliance Package.

Adding Video/Audio Files

To add video or audio files to the Compliance Package, add Vault link annotations to the storyboard document as desired and bring forward any Vault link annotations from previous versions.

You can indicate that a video or an audio file should be included in the Compliance Package using the Final Video/Audio rendition type. If you have more than one video or audio file, we recommend using supporting documents or uploading them as a ZIP file to the eCTD Submission Package rendition type.

To use the Final Video/Audio rendition method, add the video or audio file to the storyboard as the Final Video/Audio rendition type. You can then generate the Compliance Package, selecting the storyboard along with the other documents.

When generating the Compliance Package, Vault automatically creates two (2) clean versions in the same section: one (1) copy of the storyboard, and one (1) copy of the Final Video/Audio rendition. If you annotated the storyboard, then Vault additionally creates one (1) copy of the storyboard with Vault link annotations converted to relative PDF links.

If the promotional material is an audio or video file, you’ll need to upload the file as a new document version after generating the Compliance Package, replacing the storyboard document. This ensures that the promotional material reaching a Steady state is the audio or video file, not the storyboard.

To use the supporting documents method, upload your video and audio files as standard eCTD subtypes under the Supporting Documents document type. Then add the uploaded file to the promotional document using the eCTD Support Documents relationship on the promotional material. You can also upload your storyboard as the supporting document to the Final Audio/Video file.

Preparing to Generate Multiple Compliance Packages

Before generating multiple Compliance Packages, you’ll want to verify that your documents are in order and that required fields are populated. This allows Vault to correctly validate documents.

On your documents, verify that:

  • The Product field is populated with at least one (1) value.
  • At least one value in the Product field is associated to a United States Application
  • The Professional / Consumer field is populated and is set to either Professional or Consumer
  • The Health Authority Submission field is set to either FDA 2253 or FDA 2253 Accelerated Approval
  • The document type is not eCTD Submission Ready Documents, Supporting Documents, or Health Authority Form

When available, Vault automatically populates most Compliance Package metadata during bulk generation using from the following locations in the system:

Compliance Package Field Default Data & Location
Name The custom naming format defined in your Vault’s document type configuration
Product The Product field on the promotional material
Secondary Brands The Product field on the promotional material
Application Any United States Application associated to the primary product
Secondary Brands Application Any United States Application associated to secondary products where the Application type matches that of the primary Application
Professional / Consumer The Professional / Consumer field on the promotional material
Compliance Package Type The Health Authority Submission field on the promotional material
Country Defaults to United States
Responsible Official The Responsible Official field on the primary Application object record

You must manually populate the following fields:

  • Correspondence Letter
  • Submission Date
  • Reg Comments to FDA
  • Promotional Material Document Type*
  • Launch Material Type
  • Dosage
  • Indication
  • Any custom fields

* The Promotional Material Document Type must be manually populated on Pre Clearance packages. Vault automatically populates the field on Post Marketing packages.

Generating the Compliance Package

To generate a Compliance Package:

  1. Select the appropriate documents.
  2. Click the Actions menu and initiate a bulk action.
  3. On the Refine Selection page, select the promotional pieces you want to use to create the eCTD Compliance Package.
  4. Click Next.
  5. Under Generate Compliance Package, select which package to generate.
  6. Click Next.
  7. On the Edit Details page, complete the required fields.
  8. Select Yes or No under Include Linked References to determine whether Vault creates relative PDF links.
  9. Click Next.
  10. On the Confirmation page, check that the information displayed is correct.
  11. Click Finish.

Vault notifies you after Compliance Package generation is complete. The process may take several minutes to complete.

PromoMats does not submit the Compliance Package to the FDA. You’ll need to move the generated Compliance Package through its workflow for review and approval. Then, you can export the generated Compliance Package to a separate publishing tool to submit it to the FDA. You can then mark the binder as Submitted in PromoMats.

Organizations with a PromoMats and a RIM Vault can configure a standard Vault to Vault connection, enabling seamless flow from compliance package generation in PromoMats to package submission in RIM.

Generating Multiple Compliance Packages

When configured, you can also generate multiple eCTD Compliance Packages at once.

Vault automatically groups documents based on the following fields:

  • Product
  • Professional / Consumer
  • Health Authority Submission

To generate multiple Compliance Packages at once:

  1. Select the appropriate documents.
  2. Click the Actions menu and initiate a bulk action.
  3. On the Refine Selection page, select the promotional pieces you want to use to create the eCTD Compliance Packages. Then, click Next.
  4. Under Generate Compliance Package, select Create eCTD Compliance Packages. Then, click Next.
  5. Vault may indicate where there are validation errors. If there are, exit the action to resolve the error and then try again.
  6. If prompted, select the Primary Product for each group. Vault prompts you to select the primary product if a document in the selection includes more than one (1) product or if more than one (1) product is associated with a US application.
  7. Select a Primary Product to apply in bulk and click Apply. This bulk change only applies to groups containing the selected product. For example, if you select Cholecap for some groups and WonderDrug and Natevba for others, selecting WonderDrug as the main Primary Product only applies to the WonderDrug groups.
  8. Click Next.
  9. On the Preview Compliance Packages page, review and edit package details. If present, click to complete any blank required fields.
  10. Click Next.

Vault notifies you once all of the selected Compliance Packages are generated. The process may take several minutes to complete.

Correcting Errors & Troubleshooting the Compliance Package

After generating Compliance Packages, you can review the binders and make changes to the components, such as the 2253 or Supplementary Forms or relative PDF links.You can also troubleshoot any validation errors encountered during bulk generation. For more information on package generation errors, see Correcting Errors in eCTD Compliance Packages.

Exporting the Compliance Package

After the eCTD Regulator approves the binder, the Compliance Package Publisher can perform the Export Compliance Package user action, download the ZIP file, and extract the documents. The Compliance Package Publisher can then import the documents into a RIM Publishing Vault.

To import the Compliance Package to RIM Publishing Vault:

  1. Upload the ZIP file into a RIM Publishing Vault.
  2. Create a Submission Content Plan .
  3. Match documents from the Compliance Package to the content plan structure.
  4. Using RIM Publishing , prepare the content for submission to the FDA.

If you need to edit the package content while working in the RIM Publishing Vault, you’ll need to return to PromoMats, move the binder to the Revise and Resubmit state, and update the contents.

When the package is finalized for submission in RIM Publishing, you can submit the package to the FDA . After submitting the Compliance Package, return to your PromoMats Vault and move the binder to the Submitted state. You’ll also need to move the promotional material to the Steady state.

Compliance Package Components

Vault includes the following documents in each package:

Package Type Documents Included
Post Marketing Compliance Package 2253 form
Supplementary form if there is more than one product
Product Labelling material
Clean Material
Metadata.xml

If references are included:
Annotated Material
Annotated Label
Annotated Reference
Pre-Clearance Compliance Package (Center APLB) 2253 form
Supplementary form if there is more than one product
Product Labelling material
Clean Material
Metadata.xml
Correspondence Letter

If references are included:
Annotated Material
Annotated Label
Annotated Reference
Pre-Clearance Compliance Package (Center OPDP) Product Labelling material
Clean Material
Metadata.xml
Correspondence Letter

If references are included:
Annotated Material
Annotated Label
Annotated Reference

The binders include new copies of the specified documents rather than the exact documents selected.

The following permissions and document type and role permissions now control the ability to work with eCTD Compliance Packages. You must apply the document role permissions to states in the lifecycle your promotional material is using. By default, this is the Material lifecycle.

Type Permission Label Controls
Security Profile Object: Center: Read Ability to create, review, and/or approve the eCTD Compliance Package.
Security Profile Object: Promotional Material Document Type: Read Ability to create, review, and/or approve the eCTD Compliance Package.
Security Profile Object: Indication: Read Ability to create, review, and/or approve the eCTD Compliance Package.
Security Profile Object: Dosage: Read Ability to create, review, and/or approve the eCTD Compliance Package.
Security Profile Object: Product Indication Join: Read Ability to create, review, and/or approve the eCTD Compliance Package.
Security Profile Object: Promotional Material Information: Read Ability to review and/or approve the eCTD Compliance Package.
Security Profile Object: Promotional Material Information: Create Ability to create the eCTD Compliance Package using the bulk action with relative PDF links automatically created and correspondence letter populated.
Security Profile Object: Indication: Edit Ability to edit the Indication object and create object records.
Security Profile Object: Dosage: Edit Ability to edit the Dosage object and create object records.
Security Profile Object: Product Indication Join: Edit Ability to edit the Product Indication Join object and create object records.
Document Type eCTD Submission Ready Documents: Create Binder Ability to create eCTD Submission Ready Document binders.
Document Type eCTD Submission Ready Documents: Create Document Ability to create eCTD Submission Ready Document type documents.
Document Type Health Authority Form: Create Document Ability to create Health Authority Form type documents.
Document Role Material: View Content Ability to generate the eCTD Binder and all applicable documents when linked references (relative PDF links) are included. Add this permission to the state the document is in when the bulk action is performed to create the eCTD binder.
Document Role Reference: View Content Ability to generate the eCTD Binder and all applicable documents when linked references (relative PDF links) are included. Add this permission to the state the document is in when the bulk action is performed to create the eCTD binder.
Document Role eCTD Submission Ready Documents: Download Source Ability to export the compliance package.
Document Role Edit Document Ability to add documents to the binder and regenerate the Compliance Package.
Document Role Version Ability to add documents to the binder and regenerate the Compliance Package.