Ectd building tool

The in-build technical validation ensures your submission is valid according the latest validation criteria provided by the authorities. Where required, we can provide validation scripts and documentation for your records. Through the use of a parent-child dossier concept, DOCmanager, as an add-on to eCTDmanager, enables you to readily generate responsive templates for multiple submissions through simple country level changes.

Any changes you make to the parent dossier are automatically inherited by the child dossier, thus eliminating the need for revalidation. Reuse the content for dossiers based on different submissions scenarios, thus reducing the efforts associated with compiling and maintaining multi-region product dossiers. The RLPmanager module add-on for report level publishing gives you the power to compile and export files into a single format eligible for submissions in eCTDmanager or any other electronic submission management software.

Use drag-and-drop to create, compile, validate and version clinical studies, or edit them at a later date. It significantly reduces the time require to update variations. RLPmanager is a module for advanced report level publishing.

It is designed to optimise pre-publishing activities and support clinical study departments in managing and publishing clinical and non-clinical study reports that later become part of eCTD or NeeS submissions.

Now you can get to market faster. Download product information. Download module information. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach. Click here for more details. To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Tip: Build and maintain a knowledge base by staying informed about existing, new, and updated eCTD-related tools and information.

Tip: Plan and prepare early for electronic submission and obtain clarification from the appropriate Review Division in advance. For submission-related questions, email esub fda.

Submit only FDA fillable forms e. Do not submit scanned images of FDA fillable forms. See the FDA Forms. Also, ensure that documents and files prepared by third parties are compliant with these specifications.

Tip: Have questions? Ask for clarification by writing to esub fda. We have also been able to study new products and extend our portfolio of services in order to offer an efficient service to our clients, providing value and quality to companies, and offering customised and adequate solutions to each of their needs.

There are three fundamental aspects that distinguish us from the competition; we offer quality at a competitive price, we have a personalised customer service with immediate attention, and lastly simplicity in the implementation and use of our solutions.

That is why the motivation and the integration of everyone at the company are fundamental to continue growing together. Our experts will offer you personalised attention, guaranteeing total confidentiality.

The name of LATOK was chosen due to the existence of the group of mountains called Latok, located in the valley of the Biafo glacier, since our company shares a series of characteristics with the mountaineers that try to climb these summits.

Characteristics common to our business philosophy such as courage, eagerness to excel, technical preparation, organisation, exploration, control, risk assessment, loyalty, responsibility, honesty. This website uses its own and third-party cookies for functional purposes allowing web browsing , to optimize browsing and personalize it according to your preferences as well as to show you advertising based on your browsing profile eg pages visited.

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