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
Pharma Regulatory Services in the US
Boost US pharma success and learn how we drive strategic Regulatory Submissions as we explore real case studies in this blog.
Driving Digital Innovation in Regulatory Submissions
Drive digital innovation in Regulatory Submissions. Read this blog to discover how we transform submission strategies.
Streamlined Regulatory Approval and Compliance Services with AI-Powered Solutions
Accelerate Regulatory Approvals with AI-powered solutions. Read this blog and learn how we streamline compliance.