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.

Talk to an expert
Contact our consultants

Investigational medicinal product dossier

Designed for real regulatory decisions

The IMPD is not a theoretical document. It is assessed, questioned, and relied upon by authorities when deciding whether a clinical trial may proceed. For sponsors, this makes the IMPD a matter of accountability.
At KLIFO, the IMPD is prepared and maintained with the expectation that it must withstand regulatory scrutiny throughout clinical development, not just at the initial submission.

When an IMPD typically becomes critical

Clients typically engage KLIFO in situations where regulatory expectations increase or documentation must withstand formal authority review.

In all cases, the underlying issue is the same: the IMPD must accurately reflect the current state of the product and demonstrate that risks are understood, justified, and controlled.

A first clinical trial application is approaching and the quality package must be compiled into a regulatory-ready dossier.

A project moves from Phase I into Phase II or III, where authorities expect a higher level of manufacturing control, stability justification, and process understanding.

Manufacturing is performed outside Europe, and the existing documentation does not meet European regulatory expectations.

Authorities raise questions or request clarification that require a structured, defensible response.

Product or process changes trigger the need to assess whether a substantial modification must be prepared and submitted.

image-14

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.

How regulatory risk is reduced

The IMPD is challenged when the rationale is unclear, the structure is weak, or the sponsor appears not to be in control of the product.

KLIFO reduces this regulatory risk by:

Applying a phase-appropriate, risk-based approach and thereby balancing the need for documentation.

Ensuring that manufacturing processes, controls, specifications, and stability strategies are internally consistent and defensible.

Actively managing the output from contract manufacturers with regulatory expectations.

Identifying issues likely to trigger questions, addressing them proactively in the dossier.

Establishing a clear regulatory baseline that supports future change management and substantial modification assessments.

image

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.

How this fits into the broader development journey

The IMPD sits at the intersection of strategy and execution. It draws on detailed technical work, but its impact extends far beyond a single submission.

KLIFO therefore approaches IMPD delivery as part of an integrated development framework, ensuring a robust albeit living document that supports all phases of development.

Drug development

where the dossier reflects overall development strategy and clinical phase progression.

Read about drug development

CMC development

where manufacturing, control strategies, and stability programmes are translated into regulatory-ready documentation.

Read about CMC development

Regulatory affairs

where submission strategy, authority interaction, and lifecycle management are coordinated.

Read about regulatory affairs
klifo_miljø-027

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.

Klifo, Glostrup. 07/10-2025

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.

Let’s talk