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Regulatory Operations Services

Regulatory Operations (RO) is your essential partner in Regulatory Affairs, streamlining submissions and ensuring seamless compliance for (bio)pharmaceutical products and medical devices.

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.

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.

Your Trusted Partner in Regulatory Operations Consultancy

Regulatory Operations can be considered as a complicated and challenging process. However, our dedicated team has decades of experience collaborating with regulatory agencies worldwide to ensure submissions are precise, compliant, and timely.

Our approach focuses on a thorough assessment at the start of a project to understand your specific requirements. We can support you with planning, coordination, management, and execution of activities related to publishing services. In the same way we can support you with activities related to the development, technical compliance, submission, and maintenance of regulatory documents. With our in-house expertise in numerous process components of Regulatory Operations, we customize our services to meet your objectives. 

We offer a range of specialized RO services within the following subdivisions and can provide additional services as needed.

Examples of services we provide for (Bio)pharmaceuticals are:

eCTD compiling and publishing
RO Support and Helpdesk
Document Management System (DMS, including QMS)
Submission Preparation Support
Electronic Submission Support
Regulatory Information Management System (RIMS)

Examples of services we provide for Medical Devices are:

Project management including submission/certification planning
Quality System operations
Medical Device Technical documentation management
Submit Conformity Assessment requests with EU Notified Bodies
Technical Documentation templates (MS Word and Excel)
Advise on the documentation templates
Submission archiving
Technical File submission PDF’s including content index and navigation.

Whether you need support in Regulatory Operations for (Bio)pharmaceuticals or for Medical Devices, please reach out to us. 

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Approach & Expertise

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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Our Office
Industriestraat 14
5391 BR Nuland
The Netherlands
Email
[email protected]
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Starodub – a team of experts in regulatory affairs

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Femke Jacobs
Senior RA Manager

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