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.

99%

on-time submission rate

76,000+

submissions to regulatory authorities, without any Refusals to File (RTF)

33+

years of regulatory service experience

What are the benefits?

Local regulatory expertise, submission / project management with sizeable and scalable global delivery centers

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

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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

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