FHIRworks
Reduce errors, accelerate timelines, and simplify compliance
Complex submissions, simplified by your process
As the life sciences industry becomes increasingly data-driven, the regulatory submission process is growing more complex, yet disconnected systems, manual processes, and lack of structured data often lead to:
Delays in filing and approvals
Resource-heavy document generation
Regulatory scrutiny around data traceability and auditability
Risk of regulatory non-compliance and costly delays
According to the FDA, 21.6% of submissions fail due to technical errors like missing study data, formatting issues, and improper eCTD structuring, leading to median approval delays of 435 days.
Revolutionizing Regulatory Submissions
Designed for regulatory teams, FHIRworks delivers seamless, automated integration of clinical and regulatory data into your structured content authoring tools.
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Faster Submissions
Automate document creation and validation for faster, error-free submissions that will drive faster submission timelines and save hundreds of man hours and accelerate market access by cutting cycle times from months to weeks.
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Higher First-Pass Approvals
Built-in structure and real-time formatting and validation ensures submissions are complete, accurate and properly structured for regulatory review.
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Future-Ready Regulatory Operations
Aligned with evolving regulatory data standards (e.g., FHIR, eCTD, IDMP), FHIRworks provides field-level traceability, GxP audit readiness, and alignment with PQ/CMC, IDMP and eCTD 4.0.
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Peace of Mind
Rest easy knowing that FHIRworks streamlines the creation of submission-ready documents by transforming structured data into validated eCTD content - automatically.
Insights from NNIT
Articles
Life Sciences, Regulatory Affairs, Data
Navigating the Transition from XEVMPD to PMS: Preparing for IDMP Compliance
Online Events
Life Sciences, Regulatory Affairs
A Practical Guide to IDMP Compliance
Online Events
Life Sciences, Regulatory Affairs
First Time Launch Alliance: Paving the Path to Successful Pharma Product Launches
Online Events
Life Sciences, Regulatory Affairs
Success for First-Time Drug Launches: How Early IDMP Adoption Reduces Risk & Accelerates Approval
White Papers
Life Sciences, Data, Clinical, Drug Safety, Regulatory Affairs
Ensure that your critical data is trustworthy
Online Events
Life Sciences, Regulatory Affairs
Automated Regulatory Data Extraction and Verification
Articles
Life Sciences, Regulatory Affairs
Unlocking the Potential of Regulatory Data Requires Adoption of Artificial Intelligence and Machine Learning
Why Choose FHIRworks?
Native HL7 FHIR Alignment
Works with existing systems– no need to replace infrastructure
Built by experts in regulatory, GxP, and IT system architecture
Faster decision-making during the regulatory process
