Creating Corporate Entities

  • The Process of Creating a Corporate Entity

    • Starting the Process

    • The Process of Structural Definition

    • The Process of Narrative Definition

    • The Entity Creation Tracks

  • Corporate Entities - creation steps

  • Corporate Entities - definition stages

The creation of any Corporate Entity consists of a structural definition process and a narrative definition process.

Due to the hierarchical nature of Corporate Entities, their creation is interconnected and is done in many steps.

Also, Corporate Entities go through several stages during their creation.

The Process of Creating a Corporate Entity

The following phases are defined in the process of Corporate Entity creation:

  • starting the process
  • structural definition process
  • narrative definition process

During the process of a Corporate Entity creation, the entity creation track is maintained, providing an interrelation between the entity creation steps.

Starting the Process

The process is initiated by the receipt of the "basis for creation" type of document by the appropriate corporate entity person and its processing by Enriched Email Client.

All these processed email messages are displayed on the sub-application form "Correspondence" on the appropriate “Corporate Entity Creation/<Corporate Entity>/Structural Data” application form. Choosing one of them and returning to the application form starts the entity creation process.

The Process of Structural Definition

The process is performed using one of the application forms for structural definition, where the structural data defining the Corporate Entity are entered into the eCTD Integrated Information System Database. A minimal set of structural data for each class of Corporate Entities is specified with the (*) and they are a prerequisite for the insertion of the record in the eCTD Integrated Information System Database.

During the structural definition process a "directory tree with replacement entity definition documents" necessary to narratively define the Corporate Entity is created.

The structural definition process must be fully completed in order for the Corporate Entity to be used to define Corporate Entities of a higher structural level.

The Process of Narrative Definition

The process consists of creating narrative "entity definition documents" and uploading them to the Corporate Documentation Cloud. Uploading is done using the "directory tree with replacement entity definition documents",  previously automatically created during the structural definition process, and the application form for uploading entity definition documents.

 

The narrative definition process does not have to be fully completed for a Corporate Entity to be used to define Corporate Entities of a higher structural level. However, the process must be completed for the Corporate Entity to be part of the eCTD initial submission used as the documentary basis of the Corporate Project.

The entity creation tracks

The process of creating a structural hierarchy of Corporate Entities is divided into XIII steps and the whole process takes place on two entity creation tracks, the substance track and the medicinal product track.

The substance track, starting from the global/basic entity Substance and leading to the Marketed Substance - Production Chain

and

The medicinal product track, starting from the global/basic entity Substance and leading to the Medicinal Product.

At the end, both tracks merge to produce Medicinal Product - Preparation Production Chain defined as a unique combination of a Medicinal Product and the Marketed Substance -  Production Chains.

It is important to note that a Medicinal Product - Preparation Production Chain, is the final result of the process of Corporate Entities creation. This Corporate Entity is used, based on the managerial decision, to create an Active Substance Medicinal Product Regulatory Dossier where the first Marketing Authorization Application (MAA) Project is conducted.

Corporate Entities - creation steps

Due to the hierarchical nature of Corporate Entities, their creation and structural definition is classified into XIII steps. In each step, structural definition of several entity classes is initiated and/or completed.

A composition of unique synonym "var" is defined for each entity class and it is generated during entity creation process. These "var" synonyms are used for template directory paths and document names definitions and automatic generation of project initial submissions.

A Corporate Entity's first insertion in the eCTD Integrated Information System Database automatically generates a unique "var" abbreviation for the entity. Using the template directory tree and documents names for the appropriate entity class and the assigned unique "var" abbreviation a directory tree with replacement entity definition documents is generated. These documents  can be independently created and uploaded. When all replacement documents are replaced with narrative documents Corporate Entity is narratively defined. When structural and narrative definition processes are completed Corporate Entity is assigned status “completely defined - draft”. 

Initiation step Completion step Corporate Entity Class Corporate Entity's "var" synonym
I step I step Substance subst
I step I step Reference Medicinal Product refmedprod
I step I step Organization org
I step I step Organization Contact cv
II step II step Marketed Substance mrktsubst
II step III step Marketed Substance - Production Chain substprodchain
II step IV step Pre-Clinical Tests pclt
II step V step Clinical Trial - Generic Investigational Medicinal Product ct
II step II step Medicinal Product bassed on the Reference Medicinal Product medprod
III step III step Generic Investigational Medicinal Product gimp
III step IV step Medicinal Product based on the Ref. MP - Preparation Production Chain medprodchain
IV step IV step Generic Investigational MP - Preparation Production Chain medprodchain
V step V step Pre-Clinical Tests Dossier/First Pre-Clinical Tests Project pcltdoss
V step V step Medicinal Products based on Ref. MP Regulatory Dossier/First Medicinal Product MAA Project gmedproddoss
VI step VI step Clinical Trials Dossier/First Clinical Trial - Generic Investigational Medicinal Product Project ctdgimp
VI step IX step Clinical Trial - Innovative Investigational Medicinal Product ct
VI step VI step Marketing Campaign - OTC Medicinal Product(s) mrktcgmp
VII step VII step Generic Medicinal Product gmedprod
VII step VII step Innovative Investigational Medicinal Product iimedprod
VII step VII step Promotional Material Production Chain - OTC Medicinal Product(s) pmprodchain
VIII step VIII step Innovative Investigational Medical Product - Preparation Production Chain medprodchain
VIII step VIII step Generic Medicinal Product - Preparation Production Chain gmpprodchain
VIII step VIII step Marketing Campaign Dossier/First Marketing Campaign Project - OTC Medicinal Product(s) mcdotcmp
IX step IX step Generic Medicinal Products Regulatory Dossier/First Generic Medicinal Product MAA Project gmpd
X step X step Clinical Trials Dossier/First - Clinical Trial - Innovative Investigational Medicinal Product Project ctdiimp
XI step XI step Innovative Medicinal Product imedprod
XII step XII step Innovative Medicinal Product - Preparation Production Chain medprodchain
XIII step XIII step Innovative Medicinal Products Regulatory Dossier/First Innovative Medicinal Product MAA Project nmedproddoss

The creation of a new Corporate Entity in the eCTD Integrated Information System must be instigated with a "basis for creation"  type of document containing decision for the introduction of a new Corporate Entity into the corporate business. The decision must be sent to one of the top level corporate entity persons via Enriched Email as an attached document appropriately classified. Details and justification of such a business move together with necessary resources must be given in this document and should be signed by a corporate person with appropriate authority.

Definition of a new Corporate Entity consists of the definition of structural data stored in the eCTD Integrated Information System Database and the definition of a narrative and multimedia documents stored on the  Corporate Documentation Cloud.

Also stored In the eCTD Integrated Information System Database are the links between Corporate Entities and the entity definition documents used for their narrative definition.

The creation of a Corporate Entity is initiated on one of the entity creation application forms when a new core sequence is initiated in the eCTD Integrated Information System Database. All subsequent structural and narrative definition actions are associated with that sequence.

The whole process of defining Corporate Entities begins with the definition of Basic Corporate Entities and goes gradually upwards, level by level.

Corporate Entities - definition stages

For each entity class, structured data is first entered into the database using the appropriate application form to create a new Corporate Entity. For each entity class the minimal and complete set of structural data are defined. A minimal set of structural data is designated with (*) on the application form, and it has to be provided to save the record in the database. If only minimal but not complete set of data is entered the Corporate Entity is assigned status "incompletely structurally defined". Such a Corporate Entity can be used in the Enriched Email Client as a topic to collect additional data and complete the process of structural and narrative definition.

For "incompletely structurally defined" Corporate Entities, additional structural data can be entered in the same application form, used for the creation of new entities. At the end of each structural data entry, using the (SQL) procedure specially developed for each class of Corporate Entities, the completeness of the entry of structural data is checked and the entry is assigned the appropriate structural status. When all structural data are entered the process is completed and entity is assigned the status "completely structurally defined".

Only Corporate Entities with that status can be used to define Corporate Entities of the next higher level. 

At the insert of the structural data record into the database, using the appropriate template and business rules, a directory tree with replacement entity definition documents is generated required to completely narratively define the Corporate Entity.

As the required narrative files are created, they can be uploaded independently, one at a time, to the Corporate Documentation Cloud using the application form for uploading new entity definition documents.

After each file upload, the narrative completeness of the uploaded files is checked and if the result is positive, the status of the Corporate Entity is set to “completely defined - draft”. 

When first submitted to Health Authorities or other Business Partners, the status of Corporate Entities and their narrative files is set to “completely defined - engaged”.

Only Corporate Entities with the status “completely defined - draft” and "completely defined  - engaged" and their documents can be part of various submissions submitted to Health Authorities or other Business Partners.

Therefore, each Corporate Entity from its creation passes through several stages which are automatically set/changed:

  • Incompletely structurally defined entity
    when first recorded in the database
  • Completely structurally defined entity
    when the structural definition is completed
  • Completely defined entity - draft
    when the structural and narrative definition are completed but the entity is not used for business purposes directly or indirectly
  • Completely defined entity - engaged
    when first time used for business purposes internally or externally