Consultation Services

IND/CTA-Enabling Consultation

Navigate your preclinical-to-clinical transition with confidence. We provide strategic Investigational New Drug (IND)/Clinical Trial Application (CTA)-enabling consultation to support study design, regulatory planning, data gap analysis, and risk mitigation. Our experts help ensure your development program meets FDA and global regulatory expectations—saving time and reducing uncertainty.

CRO Consultation

Accelerate your research with expert CRO consultation tailored to your program’s needs. We offer guidance on study design, model selection, vendor evaluation, and project planning to help you navigate outsourced research efficiently. Our team ensures alignment with scientific goals, timelines, and regulatory standards, maximizing value from your CRO partnerships.

With the FDA increasingly rejecting drug applications over manufacturing and data integrity issues, early alignment with GMP standards is critical. Through our partnership with a leading biomanufacturing training provider, CASTL, we help ensure your outsourced research meets the quality and compliance expectations necessary for regulatory success.