Regulatory Submission Management and Publishing Services
Navigating complex regulatory frameworks to deliver first-time-right submissions
At Navitas Life Sciences we offer comprehensive Regulatory Submission Management and Publishing Services supporting the full product life cycle, from initial submission to post-approval changes and updates. Our experienced team of 250+ Regulatory experts support organizations in the execution of the processes and activities involved in preparing, organizing, and submitting regulatory documentation to health authorities for the approval of drugs, medical devices, biologics, and other healthcare products, streamlining the approval processes, adhering to regulatory guidelines, and increasing the likelihood of successful product approval.
Our Regulatory Submission Management and Publishing services include:
Document Authoring and Compilation
We provide Document Authoring using our fully-validated pharmaREADY® DMS which has CTD templates from Module 1 to Module 5 and Compilation with pharmaREADY® eCTD for various applications, including:
- Investigational New Drug (IND)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Marketing Authorization Application (MAA)
- Biologics License Application (BLA)
- Clinical Trial Application (CTA)
- Drug Master File (DMF)
Publishing Management
We provide Publishing Management services using pharmaREADY® tools for pre- and post-approval submissions for eCTD, NeeS, and Paper formats.
Archival Management
Utilizing pharmaREADY® DMS, we equip your organization to securely manage a wide range of business documents.
CASE STUDY
A unique partnership model drives 30% efficiency gains in Regulatory Operations
Learn how a shift from vendor to strategic partner, grounded in mutual trust and shared accountability, delivered lasting results for a top 5 pharma company.
CASE STUDY
Delivering Regulatory Excellence: Supporting China FDA Submissions
Learn how we enabled a seamless, compliant submission process in one of the world’s most demanding markets.
BROCHURE
Meeting global Regulatory requirements with pharmaREADY®
Discover more about our innovative Regulatory technology to drive accelerated compliance and deliver first-time-right solutions
Our compelling credentials speak for themselves…
BLOGS
PharmaREADY User Group 2026
Key insights from an industry conversation on eCTD 4.0, AI-powered innovation and regulatory technology
Preparing for eCTD 4.0?
Discover the five critical mistakes organizations make during eCTD 4.0 adoption and learn how PharmaREADY can support the transition.
27 YEARS LATER: FDA REVISITS CONTAINER CLOSURE SYSTEMS
Discover what the new draft guidance means. Expert insights from Mallikaarjunan, SVP