Now you do have a choice! 

Introducing Regxia’s newest service: e-architec.

A union of Regxia’s global expertise with Lorenz’ docuBridge® and eValidator™ e-architec is creating the industry standard for e-submissions:

• Electronic project management including submission compilation, QA, bookmarking and hyperlinking.
• Document management and training so that authoring is streamlined and consistent throughout the full product development cycle.
• Real-time secure access to review and comment on e-submissions throughout the process.
• Validation in accordance with current international specifications.
• FDA Gateway submission.
• A training environment which develops familiarity and skills to enable you to progress to in-house electronic submission development.
• Access to Regxia’s industry-leading strategic consulting team when required.

Outsourcing of eCTD publication is a strategic partnership.  If you are looking to gain e-submission experience and knowledge with a long-term plan to implement an in-house system, e-architec is a perfect fit! Or, you can choose to partner with Regxia and use our submission management system as long as you like.

With e-architec, we offer services to drive a product’s entire life-cycle, from early stage development through post-approval changes and variations.  Some customers have chosen to utilize all available services and have e-architec and Regxia as their ‘virtual regulatory department', whereas others have selected only those services that will complement and enhance their existing regulatory infrastructure.  No matter the choice, e-architec will adapt to your needs! 

Communication between you and the Regxia team is established early in the relationship, and this close communication ensures the success of all of our projects.

e-architec provides you with your own dedicated and secure ASP docuBridge® V environment.  You are able to review and comment on your applications and submissions as they are being compiled, and in the process become familiar with the system.  Once you are ready to implement your own submission platform, your docuBridge® environment can be transferred to your IT environment and re-validated. Regxia will support this effort through training and SOP development to ensure a seamless transition.

e-architec also provides services to facilitate your initial transition to electronic submissions:

• Document authoring templates
• Scanning and imaging
• File format transformation
• Within-file bookmarking
• Hyperlinking
• Module-level Tables of Contents for non-eCTD submissions
• Review of datasets, data definition tables and annotated CRFs
• Study tagging file generation
• Structured Product Labeling (SPL) conversions

e-architec, the cloud-based regulatory service. Now you do have a choice!

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