Your path to FDA-approved drugs starts here.

At Maxeome, we help companies in dermatology and aesthetic medicine navigate the complex regulatory Investigational New Drug (IND) process. We ensure your IND submission is scientifically sound, regulator-ready, and aligned with your clinical goals.

Investigational New Drugs

What We Do

Pre-IND Consultation Preparation

We help you request and prepare for SFDA/FDA pre-IND meetings—including writing the briefing package, developing key questions, and providing regulatory context. These early engagements can save months in development.

IND Strategy & Planning

We determine if an IND is required based on your product type and intended use. For investigational dermal therapies, cell-derived biologics, or novel formulations, we develop a clear regulatory roadmap tied to your evidence strategy.

IND Dossier Preparation

We compile and review the full IND application, including:

Module 1: Administrative and regional information
Module 2: Summary documents (nonclinical and clinical)
Module 3: Chemistry, Manufacturing, and Controls (CMC)
Investigator's Brochure and study protocol design

FDA Communication Support

We manage written responses and formal meetings, ensuring all communication with the FDA is clear, evidence-based, and strategically framed.

Integration with Clinical Development

Because we also supports study design, site coordination, and medical writing, we ensure that your IND filing is not just compliant, but practically aligned with study execution and publication goals.

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