Corporate Entities

  • Classification and Main Structural Characteristics

  • Corporate Entities - Hierarchy of Structural Levels

  • Corporate Entity Persons

One of the main components of the eCTD Integral Information System for the Pharmaceutical Corporation is the Corporate Entities of that corporation. Corporate Entities, introduction of new ones, development and change of existing ones are the center of activity of every Pharmaceutical Corporation. These activities are realized through numerous Corporate Projects, each of them related to one or more Corporate Entities.

To define the framework and context for Corporate Entities structural and narrative definition, following concepts are used:

  1. Because they are very diverse in nature, Corporate Entities are classified into entity classes.
  2. For each class, the main structural characteristics used to structurally define the Corporate Entities of the class are defined.
  3. All structural data are stored into the relational database of the eCTD Integral Information System

For each class of Corporate Entities, a "directory tree with replacement entity narrative definition documents" in accordance with the eCTD specification is defined. Those documents are necessary to completely narratively define the Corporate Entities of each entity class. Narrative entity definition documents are used to narratively define a new Corporate Entity or to define development/changes to the existing one. Those documents are uploaded to the Corporate Documentation Cloud and links to them are stored in the eCTD Integral Information System.

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It is important to note that, among other things, the Corporate Entity structural definition approach enables the automatic collection of structural data necessary to generate the eCTD Application Forms and similar XML documents directly from the eCTD Integral Information System.

Each new Corporate Entity is structurally and narratively defined before it was introduced into the corporate environment. 

Development/changes to existing Corporate Entities must be structurally and narratively defined before reporting to Health Authorities and/or Business Partners.

It is important to note that the eCTD concept has been expanded to include definitions of new and changes to existing Pre-Clinical Tests and Clinical Trials. Initial submissions for Pre-Clinical Tests and Clinical Trials and Variations for Clinical Trials are defined following the eCTD concept.

It is important to note the modular structure of the system. These narrative entity definition documents, together with their directory tree defined in accordance with the eCTD specification, are used whenever the Corporate Entity is part of an initial submission to Health Authorities and other Business Partners. Using business rules and the modular structure of narrative entity definition documents, all types of initial submissions are automatically generated.

The classes of Corporate Entities are hierarchically related and their hierarchy of structural levels are extensively used to identify affected higher level Corporate Entities whenever there is a change in the Corporate Entity at a particular level.

It is important to note that by using changed and affected Corporate Entities, the Dossiers where the Corporate Entity change must be reported and authorized are automatically located and initial variations submissions are generated. Responsible corporate project persons are notified with automatically generated enriched email notifications.

Every creation or development/change of a Corporate Entity, regardless of level, generates a core sequence in the eCTD Integral Information System, and all structural definition data and links to narrative entity definition documents necessary for structural and narrative definition of a Corporate Entity or its development/change are related to that core sequence.

Corporate Entities
Classification and Main Structural Characteristics

 Following classes of Corporate Entities are defined in the eCTD Integral Information System: 

  • Substance

    • active substance

    • excipient

    • impurity

  • Organization

    • within the corporation

    • legally affiliated with the corporation

    • not legally affiliated with the corporation

  • Marketed Substance

    • standardized

    • manufacturer specification

  • Marketed Substance - Production Chain

  • Pre-Clinical Tests

  • Dossier - Pre-Clinical Tests

  • Clinical Trial

    • Clinical Trial - Generic Investigational Medicinal Product

    • Clinical Trial - Innovative Investigational Medicinal Product

  • Dossier - Clinical Trials

  • Medicinal Product

    • Reference Medicinal Product

    • Generic Investigational Medicinal Product

    • Generic Medicinal Product

    • Innovative Investigational Medicinal Product

    • Innovative Medicinal Product

  • Medicinal Product - Preparation Production Chain

    • Generic Investigational Medicinal Product - Preparation Production Chain

    • Generic Medicinal Product - Preparation Production Chain

    • Innovative Investigational Medical Product - Preparation Production Chain

    • Innovative Medicinal Product - Preparation Production Chain

  • Dossier - Medicinal Products 

    • Medicinal Products Dossier - Generic Active Substance

    • Medicinal Products Dossier - Innovative Active Substance

  • Marketing Campaign

  • Dossier - Marketing Campaigns 

Special types of Corporate Entities are “Dossiers" as they, in addition to being entities themselves, contain various types of Corporate Projects and their related activities pertaining to the creation, introduction to the market or development/change of Corporate Entities.

For each class of Corporate Entities, the main structural characteristics are specified and their definition is a prerequisite for a complete definition of a Corporate Entity. 

Detailed listing of main structural characteristics for each entity class is presented here. 

Corporate Entities - Hierarchy of Structural Levels 

The hierarchy of structural levels of Corporate Entities is extensively used to process the creation and development/changes in Corporate Entities. From a structural point of view, taking into account their interrelationship, all types of Corporate Entities can be classified into the following structural levels:

  • Corporate Entities - global/basic  and their role in the corporation

    • Substance
    • Reference Medicinal Product
    • Organization

  • Corporate Entities - I level

    • Marketed Substance - defined by:
      • Substance - global/basic
      • Organization(s) - distributor(s) - global/basic
    • Generic Investigational Medicinal Product - defined by:
      • Generic Active Substance -global/basic
      • Reference Medicinal Product - global/basic
    • Generic Medicinal Product - defined by:
      • Generic Active Substance - global/basic
      • Reference Medicinal Product - global/basic

  • Corporate Entities - II level

    • Marketed Substance - Production Chain - defined by:
      • Marketed Substance - I level
      • Organization(s) - manufacturer(s) - global/basic

  • Corporate Entities - III level

    • Pre-Clinical Tests - defined by:
      • Marketed Substance - Production Chain - II level
      • Organization(s) - Investigational Institution(s) - global/basic
    • Generic Investigational Medicinal Product - Preparation Production Chain - defined by:
      • Investigational Generic Medicinal Product - I level
      • Marketed Generic Active Substance - Production Chain - II level
      • Marketed Excipient(s) - Production Chain - II level
      • Organization(s) - global/basic
    • Generic Medicinal Product - Preparation Production Chain - defined by:
      • Generic Medicinal Product - I level
      • Marketed Generic Active Substance - Production Chain - II level
      • Marketed Excipients - Production Chain(s) - II level
      • Organization(s) - global/basic

  • Corporate Entities - IV level

    • Pre - Clinical Tests Dossier -  Active Substance - defined by:
      •  Active Substance - global/basic
      • Pre-Clinical Tests - III level
    • Clinical Trial - Generic Investigational Medicinal Product - defined by:
      • Investigational Generic Medicinal Product - Preparation Production Chain(s) - III level
      • Organization(s) - global/basic
    • Medicinal Products Regulatory Dossier - Generic Medicinal Product -  - defined by:
      • Generic Active Substance - global/basic
      • Generic Medicinal Product - Preparation Production Chain - III level

  • Corporate Entities - V level

    • Innovative Investigational Medicinal Product - defined by:
      • Innovative Active Substance - global/basic
      • Pre-Clinical Project Dossier - IV level
    • Clinical Trial Dossier - Active Substance - defined by:
      • Clinical Trial - Generic Investigational Medicinal Product - IV level
      • Organization(s) - global/basic
      • Organization(s) contact(s) - global/basic
      • Country(s) - global/basic
    • Marketing Campaign - OTC Medicinal Product - defined by:
      • Medicinal Products Regulatory Dossier - Generic Medicinal Product - IV level

  • Corporate Entities - VI level

    • Innovative Investigational Medicinal Product - Preparation Production Chain - defined by:
      • Investigational Innovative Medicinal Product - V level
      • Marketed Active Substance - Production Chain - II level
      • Marketed Excipient(s) - Production Chain - II level
      • Organization(s) performing distribution and required technological unit operations - global/basic

    • Marketing Dossier - OTC Medicinal Product - defined by:

      • Marketing Campaign - OTC Medicinal product - V level

  • Corporate Entities - VII level

    • Clinical Trial - Innovative Investigational Medicinal Product - defined by:
      • Investigational Innovative Medicinal Product - Preparation Production Chain(s) - VI level
      • Organization(s) - global/basic
      • Organization(s) contact(s) - global/basic
      • Country(s) - global/basic

  • Corporate Entities - VIII level

    • Clinical Trial Dossier - Innovative Active Substance - defined by:
      • Clinical Trial - Innovative Investigational Medicinal Product - VII level
      • Organization(s) - global/basic
      • Organization(s) contact(s) - global/basic
      • Country(s) - global/basic

  • Corporate Entities - IX level

    • Innovative Medicinal Product
      • Clinical Trial Dossier - Innovative Active Substance - VIII level

  • Corporate Entities - X level

    • Innovative Medicinal Product - Preparation Production Chain
      • Innovative Medicinal Product - IX level
      • Marketed Active Substance - Production Chain - II level
      • Marketed Excipient(s) - Production Chain - II level
      • Organization(s) performing distribution and required technological unit operations - global/basic

  • Corporate Entities - XI level

    • Medicinal Products Dossier - Innovative Active Substance
      • Innovative Active Substance - global/basic
      • Innovative Medicinal Product - Preparation Production Chain - X level

Corporate Entities - Corporate Entity Persons

Taking into account areas of expertise present in a Pharmaceutical Corporation four types of corporate entity persons are defined, namely:

  • pre-clinical entity person
  • clinical entity person
  • chemistry, manufacturing, and control - cmc entity person
  • marketing entity person

For each Corporate Entity one or more corporate entity persons are designated.

The corporate entity persons are persons responsible for organizing and participating in the structural and narrative definition of Corporate Entities within their domain of expertise.

At the first insert of the structural data in the database, depending on the Corporate Entity being defined, one corporate entity persons of appropriate type is designated. This designated person, his Assistant, or his Agent are the only persons who can define/change structural data or upload new or subsequently change the uploaded documents for the Corporate Entity they are designated. All designated corporate entity persons, their Assistants and Agents are informed of their assignment via automatically generated enriched email notifications. Also, these persons are automatically granted the system privileges necessary to perform these duties, including becoming followers of all enriched email correspondence related to the respective Corporate Entities.