Services Submissions Management

Submissions Management

If you require support with document publishing and submission management, the DLRC Regulatory Operations team brings a wealth of experience in supporting global regulatory applications across multiple formats and regions.

Medical Submissions Management

Our dedicated Regulatory Operations team can provide services to support all activities including document formatting, applying full navigational aids, compilation of eCTD applications, technical validation and submission of applications globally.

Each team member works seamlessly with our Regulatory Consultants on regulatory strategies, submission planning and tracking to ensure applications are delivered to a high standard meeting all eCTD compliance requirements and according to schedule.

To support initial marketing applications, we can offer clients access to our Veeva EDMS system which offers collaborative authoring, approval of documents and a reviewing platform to facilitate the authoring and reviewing process. This is a secure environment with a built-in robust security system.

As part of our document management services, we support the preparation of controlled documents including Standard Operating Procedure (SOPs), Work Instructions and Guidance documents.

DLRC Publishing Expertise

We support Global Submissions to FDA, EMA, MHRA and Health Canada offering expertise in:

  • New Drug Applications (NDA)
  • Marketing Authorisation Applications (MAA)
  • New Drug Submissions (NDS)
  • Investigational New Drug (IND) submissions
  • Clinical Trial Applications (CTA)
  • Investigational Medicinal Product Dossier (IMPD)
  • Briefing Books and Post Marketing Applications

DLRC Regulatory Operations Service

  • eCTD Publishing
  • Compilation of eCTD Applications
  • Lifecycle Management
  • QC Review
  • Technical Validation
  • Cloning of existing eCTD Applications
  • Baseline submissions

Submissions Management

  • Submission Strategy
  • Submission Planning and Tracking
  • Provide Content Plan Template
  • Effective Submission Timelines
  • Guidance on eCTD Lifecycle Management
  • Recommendations on combining documents and document granularity
  • Guidance on appropriate use of hyperlinks and cross reference links

Ensuring High Quality Submission Ready Documents

  • PDF Document Formatting – File Level Standards
  • OCR (Optical Character Recognition)/scanned documents
  • Embedded Fonts
  • Page Level Standards and Orientation
  • Bookmarks
  • Hypertext Links

e-Submission Gateways

  • FDA Gateway – US/Health Canada
  • EMA Gateway
  • CESP
  • IRIS/SPOR
  • MHRA Portal

DLRC Veeva Client Collaboration

DLRC can offer a collaborative authoring/approval Licence, an eCTD viewer Licence or a Combined Licence that offers full client functionality.

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