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Commence your EU trial

An Investigational Medicinal Product Dossier (IMPD) is a key regulatory document required by European regulatory authorities before a clinical trial can commence within the European Union.

Expert working

Your IMPD medical writing expert

Precision & depth

With 20 years of experience, IASON consulting provides the depth and precision the required to compile an IMPD for EU regulatory authorities.

Drug checklist
Product profile

We focus on providing a clear risk-benefit assessment based on the available data. This assessment plays a pivotal role in regulatory evaluations, determining whether the product's potential benefits outweigh its risks in the proposed clinical trials.

Drug safety checklist
Safety and efficacy

The dossier requires the author to integrate relevant non-clinical (preclinical) and clinical data. This includes studies supporting the investigational product's safety, efficacy, and pharmacology.

Scale with benefit-risk ratio

We furnish comprehensive information about the investigational medicinal product's composition, source, quality, and method of manufacture. This ensures the IMP meets all EU quality standards.

Building with four columns

IMPD writing service

IASON consulting offers a writing and review service for IMPDs. Leveraging deep knowledge and insights from countless successful submissions, we ensure your IMPD not only stands up to regulatory scrutiny but also lays a robust foundation for your clinical trial endeavors in Europe.

Two decades of experience

Countless successful IMPDs prepared 

Consulting on best approach

Request a quote

We will be happy to answer any questions you might have via e-mail or in a free online kick-off meeting. 

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