Our Expertise
With over two decades of regulatory leadership, we provide tailored, results-driven solutions that meet your program’s unique needs.
1
Global Regulatory Strategy Development
We design comprehensive, forward-looking CMC regulatory strategies that align with FDA, EMA, ICH, and global standards. Our approach helps clients anticipate challenges, minimize risks, and position assets for timely approvals and market expansion.
2
Submission Planning & Execution
From pre-IND through registration, we manage the authoring, review, and compilation of high-quality dossiers. Our team ensures regulatory submissions withstand scrutiny, securing approvals while maintaining compliance across the product lifecycle.
3
Health Authority Engagements
We lead the preparation of briefing packages, Q&A strategies, and agency meeting rehearsals. By managing interactions with FDA, EMA, and other global agencies, we help clients negotiate regulatory pathways that balance innovation and compliance.
4
Risk Assessment & Gap Mitigation
Our structured gap assessments identify regulatory, technical, and operational risks. We implement mitigation strategies to ensure uninterrupted program progression.
5
Flexible Engagement Models
We understand that every project is different. Choose from ad-hoc consulting, project- based support, or interim leadership to meet your program’s needs with agility and precision.
