Monitoring, managing and submitting new a New Animal Drug Applications in compliance with regulatory agencies worldwide is time-consuming and complex. You have to prove that the drug quality, efficacy and safety properties are suitable for the intended use. This requires to collect and organize documents from various sources while ensuring compliance with specific layout codes and norms.
Ennov VNeeS Software allows you to compile, publish and monitor your New Animal Drug Applications worldwide, in compliance with all regulatory requirements (FDA, AFSSAPS, EMA,…)
Benefits of Ennov VNeeS Software
- 3x faster roll-out than other vendors’
- 30% reduction in administrative workload
- 2x faster to submit a NADA
- Streamlines dossier life-cycle, sequences and variations management
- 1 tool to import, compile and publish of all your regulatory documents
- Significant time and cost savings
Discover Ennov’s advanced VNees Software.
Streamline your NADA publications and ensure compliance with Ennov VNeeS Software.
Ennov VNeeS Software has been designed for Regulatory Affairs of Veterinary Pharmaceutical companies. Simplify the publication of VNeeS submissions with Ennov advanced VNeeS Software. Create your NADA generating automatically the VNeeS hierachy in compliance with ICH regulations and get significant benefits:
- Document availability and aggregation
- Draft publishing
- Internal compliance check to comply with the regulatory agencies worldwide
- Metadata, access rights and submission life-cycles are fully configurable
- Streamlines compliance with FDA’s 21 CFR Part 11 requirements
Ennov VNeeS Software offers dossier templates compliant with the TIGes requirements.
From a “Pharmaceutical“, “Immunological” or “MRL“ template, you can decide at any time to publish either the entire submission, or just the part that will be dragged into the whole dossier. You can also duplicate publications to re-use for submission in another region.
Submit a dossier within 15 days with Ennov flexible and user-friendly VNeeS Software.
With over 500 customers worldwide including leading veterinary pharmaceutical companies such as Ceva our Virbac, Ennov has developed a robust turnkey solution. Using our pre-configured VNeeS Software, you can submit a dossier within 15 days without any IT skills required.
Ennov VNeeS software embeds a powerful regulatory EDMS.
In addition to advanced submission assembling and publishing features, Ennov VNeeS Software embeds a powerful document management system. Documents are dynamically updated, accessible from any device, and reliable.
- No integration needed for faster deployment and better cost-efficiency
- All-in-one approach to prepare original applications, amendments or variations 2x faster
- A Simple, turnkey solution: fully-configurable and scalable to meet your organizational requirements
The most cost-effective VNeeS Software Solution.
Ennov VNeeS software implementation cost is significantly lower than any hybrid solutions combining an EDMS engine with external publication tools. With Ennov VNeeS Software ready-to-go solution, you don’t require any additional resources for development, integration or maintenance.
Ennov VNeeS Software integrates with Ennov Regulatory EDMS for a complete Regulatory Solution.
Ennov Regulatory Solution for veterinaries is a complete cloud-based solution with powerful features that streamline your submission life-cycle management:
- Document creation via a tree structure editor
- User-friendly drag-and-drop interface and dossier validation
- Publish on paper and VNeeS formats and ensure compliance with regulatory agencies worldwide
- Metadata, confidentiality level or dossier life cycle are fully configurable
Ennov VNeeS Software offers dossier templates compliant with all regional and ICH requirements.
Automate the creation of a partial or complete hierarchical structure with Ennov VNeeS Software. Ennov VNeeS Software includes sophisticated hyperlinks and sequence management features. VNees validation is ensured prior to extraction and publishing.
VNeeS module includes sophisticated hyperlink management features.
Checks are automatically run on the links of all the PDF documents related to a submission. Invalid links are systematically reported. Therefore, you can modify the links to make them valid and insert “submission” links.
Ennov VNeeS Software embeds a VNeeS compiler and an automatic validation checker.
The automatic checks report any non-compliant element of the submission (incorrect file name, missing item, unauthorized characters, file format,…) and provide a direct access to the invalid element. This allows to make all necessary modifications before publishing.
Manage both paper and VNeeS publishing with a single tool.
With Ennov VNeeS Software you can natively create several tables of content in compliance with the regulatory guidelines. A draft mode allows you to check your VNeeS application hyperlinks at any time before publishing. In addition, Ennov VNeeS software offer all the paper publishing features.
Among all the capabilities of Ennov Regulatory Solution, our customer love:
- Batch dossiers management
- Request for Temporary Use Authorizations feature