First Time Right DMF Submissions with Navitas Life Sciences

If you own an API and your next milestone depends on a clean, fast review of your Drug Master File (DMF), this one’s for you.

We begin with a clear kick-off with clients so timelines and plans are agreed up front. Source data is organized through database management in a multitenant environment, giving teams a single, structured workspace that enables collaboration while maintaining consistency.

Authoring and review happen inside pharmaREADY DMS, which leverages integrated CTD templates and defined workflows. This structure provides document life-cycle management and tightly governed authoring practices, ensuring that CTD content remains accurate, complaint, and consistent across documents.

When the submission is ready to be compiled, our fit-and-finish automation, used with the pharmaREADY eCTD module, prepares submission-ready PDFs with the technical hygiene needed for easy dispatch to the Health Authority.

After the initial submission, Navitas SMEs continue to support clients with LCM & tracking continue in rimREADY, approvals are monitored, ongoing updates are managed efficiently, and long-term maintenance of regulatory submissions remains sustainable.

Following a standard workflow for authoring DMFs brings discipline and transparency. Teams gain a shared understanding of the actual submission process. Stakeholders can access the system to track and view dynamic reports required for submission. Queries and resolutions are managed methodically until dispatch to the Health Authority. With RIM-based lifecycle management for APIs, changes and updates are handled in an orderly, auditable way.

Our technology-enabled approach

Our approach is powered by a connected tool stack. An interlinked DMS with the pharmaREADY eCTD publishing tool anchors document life-cycle management and authoring. Submission Tracking Workload Management (STWM) helps manage workloads effectively, enabling project managers and client PoCs to review submission status at any time, plan proactively, and accelerate submission timelines. Automation of publishing tasks provides the “fit and finish” for PDFs so submissions are ready for easy dispatch without last-minute formatting scrambles.

For ongoing control, rimREADY, a web-based solution for achieving RIM excellence, enables accurate and timely regulatory submissions at optimal cost. Beyond planning and tracking, rimREADY drives resource efficiency and statutory compliance, supports impact assessments when markets or applications change, and alerts users to affected markets. The solution also brings together core capabilities such as a Medicinal Product Repository, Submissions Planning and Management, RegOps intelligence and analytics using dashboards, Product Registrations tracking and maintenance, Health Authority correspondence and commitments tracking, and Event-Based Notifications and Reports.

All of this means your DMF advances with clarity and speed, grounded in a repeatable process, informed by real-time reporting, and sustained through disciplined lifecycle management. That’s how we make regulatory submission work feel predictable instead of frantic.

To know more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it..