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Business solution

Drug Registration

Class : BPM,ECM


Category :PHARMACEUTICALS


Author : CENTER ECM POLAND


Date of issue : 2019

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What functionality does the solution contain?

  • Formation and maintenance of the register of medicines
  • Dossier of a medicinal product, including FMP (finished medical product) and API (Active Pharmaceutical Ingredients) dossiers
  • Processes for maintenance of registration process
  • Automation of work with reference drug
  • Application for the development of a new drug
  • and more...

What are the main functions of the solution?

  • Creation and support of a drug dossier
  • Collection of documents for the dossier
  • Drug registration
  • Re-registration of a medicinal product
  • Registration of changes in medical product
  • and more...

What business processes provide highly effective work with drugs?

  • Initial registration of a new drug
  • Initial registration of a new API (Active Pharmaceutical Ingredients)
  • Planned re-registration of a medicinal product
  • Planned re-registration of a API(Active Pharmaceutical Ingredients)
  • Registration of changes of medical product
  • Registration of changes of API (Active Pharmaceutical Ingredients)
  • Import/Export of dossier
  • Entering archived/historical data of registered medicines
  • Entering archived/historical data of registered API (Active Pharmaceutical Ingredients)

also marketing business processes:

  • Business processes for automation of development and printing of layouts of primary packaging
  • Business processes for automation of development and printing of layouts of second packaging
  • Business processes for automation of development and printing of layouts of instruction
  • and many important service processes...

For your convenience we have created and order:

  • Convenient and fully functional registry of medicines
  • Cataloger for storage of documents and filings of documents
  • Full support for versioning and document version control
  • and many other useful functions...

Is your business international?

We took care of the function of export/import of the drug dossier for registration procedures in other countries.

Modularity

1

Drug Registration

The module includes the following processes:
  • Development phase of FMP (finished medical product)
  • Preparation of documents for dossier
  • Development of layouts of primary packaging
  • Development of layouts of secondary packaging
  • Printing layouts of primary packaging
  • Printing layouts of secondary packaging
  • Printing of instruction
  • Registration of FMP/API
  • Submission packages layouts of FMP
  • Submodule "Contractual work on bioequivalence"
2

Regestration of changes for FMP\API

The module includes the following processes:
  • Creating a dossier for the registration of changes of FMP
  • Creating a dossier for the registration of changes of API
  • Registration of changes for FMP/API
3

Re-registration of FMP\API

The module includes the following processes:
  • Creation and updating of dossiers for re-registration of FMP
  • Creation and updating of dossiers for re-registration of API
  • Re-registration of FMP/API
  • Creation of dossier of FMP (archive)
  • Creation of dossier of API (archive)
  • Uploading Documents for Dossiers of FMP/API
  • Main objects
  • Additional service processes
4

Import/export of dossiers

The module includes the following processes:
  • Import of dossiers of FMP
  • Export of dossiers of FMP
  • Import of dossiers of API
  • Export of dossiers of API

Drug Registration:Benefits

  • Formation and maintenance of the drug register
  • Dossier of a medicinal product, including FMP (finished medical product) and API (Active Pharmaceutical Ingredients) dossiers
  • Business Processes for Registration
  • Automation of work with the reference product
  • Application for the development of a new drug
  • and more...

We got a unified environment for the work of the staff of the department for registration of medications. The most important achievement is the ability to control the collection of dossiers for registration, document saturation and full control over the deadlines for all stages. We have completely redefined our work. We have taken a big step and today it is quite difficult to imagine our work without such convenient tools that we received in the automation process.

Big job. One year. Thanks to the CENTER ECM project team - the most comfortable collaboration. We look forward to further implementation of the development of a new drug.

Let's create something amazing together.