Investigational medicinal product dossier (IMPD)
An Investigational Medicinal Product Dossier (IMPD) is a regulatory document that must be submitted to authorities in order for a clinical trial to start and continue.
At KLIFO, we prepare, update, and maintain the IMPD with a clear focus on quality, manufacturing control, and regulatory accountability across the full clinical lifecycle.
What KLIFO delivers
KLIFO delivers an IMPD as a complete, submission-ready regulatory dossier.
The deliverables include:
- A structured IMPD aligned with regulatory guidance and proportional to development phase and product type.
- A coherent quality section covering both drug substance and investigational medicinal product, including manufacturing processes, control strategies, specifications, container closure information and stability data.
- Integrated justification of development status, data gaps, and risk mitigation where full datasets are not yet available.
- Clear traceability between manufacturing changes, analytical methods, and clinical use.
- Documentation prepared to support both initial submission and controlled updates throughout the trial lifecycle.
The quality section is the regulatory anchor of the dossier. It is the part most frequently scrutinised, most likely to generate authority questions, and critical for protecting patient safety and future data validity.
Where relevant, nonclinical and clinical sections are incorporated or cross-referenced in a way that supports an overall benefit–risk assessment without unnecessary duplication.
Accountability across preparation, updates, and authority interaction
The IMPD development process does not end with clinical trial application submission. The IMPD must be maintained, defended, and updated as development progresses.
KLIFO takes responsibility across the full lifecycle:
- Preparation of the initial IMPD for clinical trial application.
- Maintenance to reflect new stability data, process optimisation, or manufacturing changes.
- Assessment of whether changes constitute substantial modifications requiring authority notification.
- Preparation of updated IMPD sections and supporting documentation.
- Support during authority interactions, including drafting and coordinating responses to regulatory questions.
Clients often rely on KLIFO as the central point of knowledge for regulatory communication, both internally and in dialogue with authorities.
Who typically relies on this deliverable
IMPD assignments most often come from:
- Small and mid-size biotech companies preparing or expanding European clinical trials.
- Sponsors working with non-European or external manufacturers.
- CMC leads and Heads of Regulatory Affairs who need confidence that the quality package will withstand regulatory scrutiny.
- Project teams preparing for partnering discussions or investor due diligence, where CMC credibility matters.
In these situations, a comprehensive IMPD is not just a regulatory requirement but a signal of development maturity and sponsor control.
Investigational medicinal product dossier
KLIFO’s value in practice
KLIFO combines strategic oversight with hands-on execution. The same highly experienced specialists who understand regulatory expectations are directly involved in reviewing data, rewriting sections, and shaping the final dossier.
Clients choose KLIFO to help structuring and compiling robust documentation and to reduce uncertainty.
If you need an IMPD that is robust, defensible, and aligned with where your development is heading, KLIFO acts as your trusted and experienced partner delivering high quality comprehensive documentation.
What is an Investigational Medicinal Product Dossier (IMPD)?
An Investigational Medicinal Product Dossier (IMPD) is a regulatory document that must be submitted to authorities in order for a clinical trial to start and continue. It provides the necessary information for authorities to assess the investigational medicinal product and decide whether the trial may proceed.
When does an IMPD become critical?
When does an IMPD become critical?
An IMPD becomes critical when regulatory expectations increase or when documentation must withstand formal authority review. This typically occurs when preparing a first clinical trial application, progressing to later clinical phases, responding to authority questions, or when product or process changes require assessment.
What does an IMPD need to demonstrate?
An IMPD must accurately reflect the current state of the product and demonstrate that risks are understood, justified, and controlled. It must also show that the sponsor is in control of the product and its development.
What is included in an IMPD?
An IMPD includes a structured dossier aligned with regulatory guidance. It contains a quality section covering drug substance and investigational medicinal product, including manufacturing processes, control strategies, specifications, container closure information, and stability data. It also includes justification of development status, data gaps, and risk mitigation.
Why is the quality section of the IMPD important?
The quality section is the regulatory anchor of the IMPD. It is the part most frequently scrutinised by authorities, most likely to generate questions, and critical for protecting patient safety and the validity of clinical data.
Does an IMPD need to be updated during development?
Yes, the IMPD must be maintained and updated throughout the clinical trial lifecycle. It is updated to reflect new stability data, manufacturing or process changes, and to support responses to regulatory questions or required modifications.