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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.
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Our team brings decades of knowledge in RIM, from small businesses to multinationals. We are experts in regulatory submissions across the world and are familiar with local regulations, therefore we can support you in navigating the complexity and variability of regulations across regions. The ability to organize, structure, provide overview and analyze is part of our DNA.

We handle information management in multiple ways.

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Learn how we can support you in meeting your business goals

  • Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
  • Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
  • At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.
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Kim Bruggink
Senior RA Manager

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We collaborate with clients and care about their patients' needs

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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.

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.

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.

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.

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Industriestraat 14
5391 BR Nuland
The Netherlands
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Starodub – a team of experts in regulatory affairs

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Kim Bruggink
Senior RA Manager

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