Investigational Medicinal Product Dossier
Regulatory authorities in the European Union require submission of an Investigational Medicinal Product Dossier (IMPD) as an integral part of a request for authorization of a clinical trial. Accovion can assist you in determining the level of documentation needed and ensures quality and completeness to facilitate faster approval of your clinical trial.
Assembling various documents that comprise the IMPD demands time, attention to detail and careful project management. Why not delegate this important task to an expert? Accovion has a solid track record of producing IMPDs that are complete, accurate and that meet all regulatory specifications. We’ll work with your team to obtain the necessary data, keep you informed of the progress, and ensure that your IMPD is produced on time.
Your choice of services
Depend on Accovion to provide one or more of the following services for your IMPD:
- Consultation on documentation needed (full or simplified IMPD)
- Full project management
- Full writing services
- Template and guidelines (we’ll work with yours or adapt ours to your needs)
- Quality control of documentation
- Electronic compilation, publishing and hyperlinking of all documentation
Adapted to your needs
Accovion’s Medical Writing and Electronic Publishing team has produced IMPDs in a variety of therapeutic areas and indications. You’ll receive well-structured, concise documentation, including an overall risk-benefit assessment. Depending on your needs, we can tailor your IMPD using individual country or European Commission guidelines for specific or multiple-country submissions. Click here to send an e-mail requesting more information.