Document Management System (DMS) Support

A Document Management System (DMS) is a computer-based system you use to store, manage, track, and organize your digital documents. Implementing a DMS offers you many benefits, regardless of your industry. It streamlines your workflow processes and document maintenance, helps you comply with regulations, reduces your risk of data loss, improves your ability to search for information, increases your collaboration, and provides you with enhanced version control.

What can we do for you?

These are some examples of what kind of DMS support we offer:

  • Unbiased recommendation of a DMS based on your requirements to ensure you don’t spend money on unnecessary features 
  • Implementation support of a new DMS to fit with your current systems and make standardized, efficient ways of working
  • Training your team on useful features and best practices that we have learned, so you don’t have to
  • Cleaning and restructuring of your DMS, to help you maintain or regain regulatory compliance
  • Fulfilling a document specialist role in your RA team, taking care of tasks such as uploading documents to your DMS, updating document properties and metadata, sending out workflows, arranging reviews and approvals to keep quality standards.

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Inge van Gaal – Rijpert
RA Manager

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eCTD (electronic Common Technical Document) ›

The implementation of eCTD worldwide has been steadily increasing as already over 50 countries have implemented eCTD. And still more and more regulatory agencies continue to adopt electronic submission standards and move away from submitting dossiers as a single PDF, in NeeS (non-eCTD electronic submission)-format or on paper. However, publishing your dossier in eCTD format can be challenging.

Submission preparation support ›

We offer Submission Preparation Support to assist you in preparing and compiling documentation required for successful regulatory submissions to health authorities such as the EMA, FDA and other regulatory bodies worldwide. Once you have authored and reviewed the dossier sections of your submission, our expert team with decades of industry knowledge, ensures your application is submission-ready.

Regulatory Information Management (RIM) ›

Regulatory Information Management (RIM) refers to the processes, systems, and tools you can use to manage and ensure compliance with regulatory requirements. It involves the collection, storage, analysis, and submission to support regulatory dossiers, product approvals, and ongoing compliance.

Electronic Submission Support ›

Upon the completion of your submission dossier, whether in eCTD or NeeS format, several avenues are available for delivering it to regulatory authorities. Among these methods is the utilization of designated electronic submission portals, which can vary, depending on the specific procedural requirements or the geographical region.
Inge van Gaal – Rijpert
RA Manager

Let's Connect

Talk to an expert