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.
ARTICLE
AI and Digital Technology in Regulatory Submissions
CASE STUDY
A Successful Regulatory Outsourcing Partnership
BROCHURE
Meeting global Regulatory requirements with pharmaREADY®
Our compelling credentials speak for themselves…
BLOGS
From ECDRP to IRP – What pharma companies need to know about MHRAs new procedure
End-to-End Regulatory Services: Compliance and speed to market
