Regulatory Support – IND & IMPD (Module 3)
At Pre-therapeutic, we provide expert support for the preparation of Module 3 (Quality) of IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) submissions. Our team combines scientific and regulatory expertise to help you build a strong CMC package for early-phase clinical development.
What We Offer
We support both the strategic planning and technical execution required for a successful submission. Our services include:
Data generation and interpretation, through:
- Coordination of required CMC studies (e.g. method development, validation, stability)
- Gap analysis of existing data
- Support with compiling documentation from CROs and CDMOs
Authoring of Module 3 documents, including:
- Drug substance and drug product sections
- Description of manufacturing processes
- Control of critical materials
- Specifications, analytical procedures, and validation summaries
- Stability data and justification of storage condition
Phase-appropriate approach
- Phase-appropriate approach, tailored to early-stage development and fit-for-purpose requirements
Whether you’re preparing for a first-in-human study or progressing to exploratory clinical trials, we ensure that your CMC documentation is complete, compliant, and scientifically sound — while remaining flexible to the evolving nature of early development.