Local regulatory expertise, submission / project management with sizeable and scalable global delivery centers
Regulatory Submission Services
Optimize business processes across the regulatory value chain.
DXC’s teams of regulatory submission experts will ensure that your life sciences organization achieves fully efficient, end-to-end submission processes. Your business will maintain compliance with country or regional regulations in multiple markets, covering document formatting, document publishing, dossier publishing, submission filing and archiving.
Additionally, we'll help your organization be ready to implement electronic Common Technical Document (eCTD) 4.0, which aims to make communication between sponsors and regulatory agencies more efficient and streamlined. We provide flexible and extensive electronic eCTD capabilities to the FDA / EMA and other agencies worldwide. DXC can tailor our service options and solution models to support clients’ individual needs.
What are the benefits?
eCTD 4.0 readiness with dedicated support from our expert team to ensure a smooth global transition.
Blended pricing models that leverage offshore centers to allow 20-30% savings versus internal operations
A team of experienced and long tenured publishers, submission managers and regulatory operations subject matter experts
Proven business continuity and disaster recovery methodologies, with a globally distributed delivery model that facilitates a flexible and scalable continuous workflow for clients.
Various service options and flexible solution models that can be tailored to support clients’ needs
Increased cost savings and convenience by eliminating the need to maintain large internal groups to handle traditional spikes in work
Our Regulatory Submission Services include:
Formatting
Quality Review & Compliance Check
- Briefing documents
- Protocols and amendments
- Clinical study reports (with structuring of appendices)
- Investigator brochures
- Narratives
- Annual reports
- Risk management plans
- Integrated summaries (ISS/ISE)
Publishing
Document-Level Publishing
- Document publishing
- Compliant navigation
- Clinical study report
- CMC
- Summaries
- Case report forms
Assembly
Dossier Publishing
- Global health authority document validation and submission
- Post-application and lifecycle management/ support
- Comprehensive transition support for eCTD 4.0
Data Entry Management
- Standardization
- Maintenance
Submission
Dossier Filing
Submission transmissions through gateway portals
Insights
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