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Regulatory Submission Services

Optimize business processes across the regulatory value chain.

Speak with an expert

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.

We provide flexible and extensive electronic Common Technical Document (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 (eCTD 4.0 readiness), submission / project management with sizeable and scalable global delivery centers

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:

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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)
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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

Data Entry Management

  • Standardization 
  • Maintenance
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Submission

Dossier Filing

Submission transmissions through gateway portals

FIND OUT HOW DXC CAN HELP YOU

Contact Us

DXC Technology (NYSE: DXC) is a leading enterprise technology and innovation partner delivering software, services, and solutions to global enterprises and public sector organizations — helping them harness AI to drive outcomes at a time of exponential change with speed. With deep expertise in Managed Infrastructure Services, Application Modernization, and Industry-Specific Software Solutions, DXC modernizes, secures, and operates some of the world’s most complex technology estates. Learn more on dxc.com.

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