IND Strategy & Submission
We review country-specific regulatory requirements against the development plan and scientific evidence, providing structured support from regulatory consultation to IND documentation, submission, and responses to requests for additional information.
Regulatory Consulting
Regulatory strategy aligned with global standards.
Early regulatory decisions about what data to submit, when, and under which design shape the pace of the entire program. ACRO provides regulatory advice grounded in the biostatistical and clinical evidence underpinning every submission.
We work as a strategic consulting partner. Sponsors engage specialist regulatory agencies to compile the full dossier, while ACRO provides the scientific foundations: design rationale, statistical justification, and dose strategy.
Why it matters
Drug development now operates within an international standards framework. ICH M12, which took effect in 2024, established new expectations for DDI studies, while the ICH E-series informs regulatory review across regions. Effective submissions address both local procedural requirements and international scientific standards, supported by consistent methodology.
What we offer
- Regulatory pathway memoranda — Pathway selection and scientific rationale
- Planning for pre-submission scientific advice
- Statistical and methodological sections for IND submissions
- Dose justification and exposure-response narratives
- Preparation of responses to regulatory questions
How we work
We focus on the design, statistics, and dose justification central to regulatory discussions. Sponsors requiring full dossier compilation or submissions across multiple regions engage specialist regulatory agencies, while ACRO provides the scientific rationale and statistical work supporting those submissions.
Related services
- PK/PD Modeling — Population PK and exposure-response modeling support dose strategy.
- Protocol Development — Protocols are designed for the intended regulatory pathway.
- Biostatistics — Design and analysis methodology underpinning submissions.