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).

 

2- 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.

 

3- eCTD-CTD Training & Workshop:

CTD “Common Technical Dossier” is the mandatory format for regulatory submissions worldwide. This course explains the rational for the CTD & eCTD. Also, provides detailed guidance on its structure and format. Bimag Solution had implemented CTD as a submission format for pharmaceutical products; Almost Global authorities (Ministry of Health) have implemented CTD submission as standard guidelines for registration of products.

 

4- Outsourcing Service Provision:

for Full marketing authorization holder and medicine meeting the Pharmacovigilance Systems in Arab Countries, to fulfill its legal tasks and responsibilities in relation to pharmacovigilance with MOH upon products’ registration, including PSMF master file and, other required documents such as; RMP and PSUR, keeping quality requirements which are those characteristics of the PV system that are likely to produce the desired outcome, or quality objectives. Also, developing and maintaining product-specific risk management systems. As well as, reviewing the PV system including its quality system at
regular intervals.

 

5- Pharmacovigilance Software Marketing / Installation:
We can serving your organization by hosting with validated Computerized PV database complied with international agreed standards ICH-E2B, to be acquired with Pharmacovigilance compliance with data migration and integration.
Hence, our licensed national PV software can manage unique use in Pharmacovigilance Safety – easy phV. Validation documents are generated and supplied by us to all customers.