Accelerate Regulatory Approvals Through Digital Transformation
Improve your Regulatory Affairs Processes
Reduce time to approval and increase confidence in regulatory submissions by modernizing how regulatory content is planned, created, managed, and submitted. Our regulatory affairs solutions leverage digital transformation, data as an asset, and AI-enabled automation to drive faster, more transparent, and more compliant outcomes across the regulatory lifecycle.
Helping clinical labs deliver smoother trial programs.
Successful trials rely on innovation, technology, and people to drive success.
Our Focus Areas
Plan
- Strategic Roadmap (People, Process, Technology)
- Data Assessment
- Solution Design & Selection
Build and Maintain
- Data Clean Up & Harmonization
- Solution Implementation/Development
- Project/Program Management
- Organizational Change Management
Run
- Ongoing Organizational Change Management (ensure adoption)
- Solution Managed Services (Optimize and maintain)
Plan
- Strategic Roadmap (People, Process, Technology)
- Data Assessment
- Solution Design & Selection
Build and Maintain
- Data Clean Up & Harmonization
- Solution Implementation/Development
- Project/Program Management
- Organizational Change Management
Run
- Ongoing Organizational Change Management (ensure adoption)
- Solution Managed Services (Optimize and maintain)
Plan
- Strategic Roadmap (People, Process, Technology)
- Data Assessment
- Solution Design & Selection
Build and Maintain
- Data Clean Up & Harmonization
- Solution Implementation/Development
- Project/Program Management
- Organizational Change Management
Run
- Ongoing Organizational Change Management (ensure adoption)
- Solution Managed Services (Optimize and maintain)
Trends We Focus On
Astrix Helps you Respond to Key Issues
TBD
- Digital records, searchable information & connected systems to support
- Increased transparency and automated workflows from data through submission (Plan, Build, Submit, Archive, Commitments & Amendments)
- Traceability of content generated & reused
- Ability to leverage Health Authority Gateways for electronic submission
- Integration of AI-driven automation for submission document validation, quality checks, and regulatory intelligence updates
- NLG for submission content authoring derived from data, unstructured content or other documents; reuse of content across documents/document types
- Regulatory Requirement management & application
- Regulatory dossiers & communication auditability
- Accuracy & reliability of submissions
- Cloud-based Regulatory Solutions
- Risk-based approaches, focusing resources on higher-risk areas & optimizing submission strategies based on potential impact
- Use of global data standards for more efficient and accurate eCTD submissions and interactions with regulatory agencies
- Automation & AI tools
- Changing regulations from Health Authorities
- Digital/Data-driven Submissions
Astrix Insights
Read some of our recent clinical content
Astrix Supports The Top Pharmaceutical Companies
The Majority of the top 100 Pharmaceutical Companies work with Astrix
Of Astrix Employees Hold Advanced Science Degrees
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Successful Lab Informatics Projects
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Professionals Globally
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LET´S GET STARTED
Contact us today and let’s begin working on a solution for your most complex strategy, technology and strategic talent services.
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