eCTD Software

 eCTD Software Marketing:

  • It is our pleasure to introduce our offers for eCTD Software’s, to meet your pre-quotation requirements, that will be sent to you upon request. There are many software’s based on the countries you need to register your product(s) in, for the purpose of exportation. We can customize the software system as per your submitted pre-quotation. Below is an offer for the most used one which is for eCTD_GCC software for only Human Drugs (Only for Arab Countries).

eCTD Software Validation:  

  • This application of eCTD software installation allows verifying and validating electronic submissions purportedly conforming to the ICH eCTD standard based on configured check options and dynamic verification rules. Validation results will be created as XML and as HTML reports.

The license cost will be inclusive taxes. The cost includes:

  1. Supply of software edition, as specified
  2. Initial Training including hands on.
  3. 1st level support by Bimag Team
  4. The software is warranted for 12 months from date of installation.

During warranty period there are no additional charges for:

  1. Operational Bug fixes (if any).
  2. Same Version Build upgrades (if any are released).
  3. Statutory upgrades released during the period.
  4. Regulatory upgrades released during the period (Chargeable).

After the warranty period AMC (Annual Maintenance Cost) charges per year shall apply payable in advance.

  1. AMC will be applicable on the license cost
  2. Three years AMC is mandatory.

Additional charges during warranty or AMC period shall apply in case of:

  1. Any additional training required by the client / user and Software Validation On patch updates.
  2. Site visit of Bimag engineer / expert to restructure installation or re-initialize due to any Hardware problem or any unknown problem that requires on-site visit.
  3. Site visit would be required for major version upgrade.
  4. Any additional applicant name to be added will be chargeable.

N.B. For registering Pharmaceutical Products to be exported to other world regions, there are other offers as per your requirements, that has to be submitted to us by the attached Pre-Quotation form answering by your requested organization/client.

Pre-Quotation Form – eCTD Dossier software