Submission Preparation Support service

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.

If you are unsure of the steps to follow during the regulatory affairs process, if you want to ensure your application is perfectly ready for submission, or if you are unfamiliar with what to do after authoring the sections for your Common Technical Document (CTD), we offer a range of services for Submission Preparation Support to assure your application is well-prepared, compliant, accurate, and positioned for successful review by regulatory authorities.

What can we do for you?

Since 2014, we have formatted thousands of documents for clients in different regions across the globe. Document submissions and our other services were primarily for the EU and US regions, and have also been successfully completed for Canada, Australia, Switzerland, and Great Britain.

To ensure we provide the most up-to-date services, we use the most current guidelines and constantly monitor updates using our internal Regulatory Intelligence system. Regularly, we check vital websites and guidelines, such as:

  • for eCTD (https://www.ich.org/page/electronic-standards-estri),
  • or more eCTD region specific (https://esubmission.ema.europa.eu/),
  • and also related to formatting (ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use – organization of CTD).

Our range of services include, and are not limited to:

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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.

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.

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