IND and IMPD for Clinical Phase 1
We secure your path to human trials by authoring a successful, agency-compliant application.
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Transitioning from preclinical studies to the first clinical trials in humans requires meticulous regulatory preparation.
The Investigational New Drug (IND) application (US) and the Investigational Medicinal Product Dossier (IMPD) (EU) are critical documents for this step. Leveraging our direct experience in authoring and successfully clearing an entire Module 3 IND application, we ensure your submission is complete, compliant, and positioned for success.
Authoring and reviewing the Quality section (Module 3/Part I) of the IND and IMPD.
Ensuring the CMC information aligns with the requirements of the FDA and EMA/EU.
Justifying the quality, purity, and stability of the investigational medicinal product (IMP).
Coordinating with non-clinical and clinical teams to ensure all required sections of the dossier are complete.
Managing the process of regulatory submission and responding to agency questions.
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We help you efficiently introduce your product to the market.
We are here to share our knowledge with you.
Call us: +48 690 462 122
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
