BFARM EVALIDATOR FREE DOWNLOAD

Navigation and service Go to: Warnings will be ignored for check-in, but if applicable you will be informed in order to help you to avoid such "inaccuracies" in the future. We are publishing eCTD submissions for of all types of applications e. Therefore, statement of a return e-mail address to which the validation report can be sent is highly recommended. Applicants will be informed if errors occur. We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry. This Page Recommend page.

Uploader:	Shahn
Date Added:	8 November 2010
File Size:	55.97 Mb
Operating Systems:	Windows NT/2000/XP/2003/2003/7/8/10 MacOS 10/X
Downloads:	8341
Price:	Free* [*Free Regsitration Required]

Therefore, the download option is still offered but is only reliable for parallel evslidator submissions: Warnings will be ignored for check-in, but if applicable you will be informed in order to help you to avoid such "inaccuracies" in the future. Technical Validation Before submitting or uploading your dossier you have to perform a validation in order to check whether your dossier does in fact comply with the requirements stated above ICH M2 eCTD v.

Therefore, the update is highly recommended. Further technical support for using the eValidator is not available.

After download and extraction the tool can be installed on a PC and can be activated without sending user details back. Therefore, statement of a return e-mail address to which the validation report can be sent is highly recommended. The end-user license agreement can be downloaded and reviewed separately before installing the software. Welcome to Exalon Your partner for high quality eCTDs, regulatory submission services and EVMPD support Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business.

We are publishing eCTD submissions for of all types of applications e. Electronic Common Technical Document.

Navigation and service

Instead, you can refer to the websites of Lorenz Life Science which ist the BfArM's service provider in this context for updates of the eValidator. This Page Recommend page. Applicants will be informed if errors occur. A correct technical validation of sequences may not be possible using previous versions of the eValidator.

Navigation and service Go to: Use of the eValidator is based on a general license for which the user does not have to pay or register. Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business. We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry.

BfArM - eSubmission - Technical Validation

Any deadlines will not start counting until the technical validation has been successful. The current changes concern the implementation of the validation criteria for eCTD v7. The BfArM additionally offers a specific validation evalidaror for parallel bfar applications FileTypex-zip-compressed 24KB File does not fully comply with accessibility standards. Errors will make it impossible to check-in your dossier, you will be requested to correct the submission and finally to re-submit the new version of that same sequence.

Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business.

BfArM - eSubmission - eValidator v

Retweet on Twitter exalon Retweeted. In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. Not a very wise move: Here you can find only in German instructions for evalidaor The previous version of the eValidator can still be used for parallel imports.