Welcome
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Our Services
Strategy, Leadership, and Support
Global Regulatory Strategy & Submission Expertise
Global Regulatory Strategy
12
- US FDA, EMA, PMDA, NMPA, & ROW
- Program design & pathway selection
- Orphan & expedited programs (Priority Review, Fast Track, PRIME)
Submission Leadership
15
- IND/CTA/NDA/BLA/MAA planning & authoring
- Gap analyses & risk mitigation (avoid RTF/CRL)
- Briefing packages & agency meetings
Operational Support
22
- Labeling & COA evidence dossiers
- Expanded access & continuity of care
- Cross‑functional leadership (Clinical, CMC, Safety)
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Engagement Models
Strategic Partnering
Building and Negotiating Strategic Alliances
Strategic Advisor
12
- Weekly senior‑level guidance
- Regulatory intelligence updates
- Rapid Q&A support
Submission Partner
15
- Hands‑on IND/CTA/NDA/BLA/MAA build
- Authoring & QC for Modules 2 & 5
- Agency meeting preparation
Project/Hourly
22
- Briefing packages & responses
- Gap analyses & roadmaps
- Targeted deliverables
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Insights
Global Regulations and Guidance
Short takes on evolving regulations, guidance, and submission best practices.
Avoiding RTFs: Top 5 Technical Pitfalls Before You File
12
From missing eCTD sections to insufficient PV data, here’s a short checklist we use before every submission.
120-Day Safety Updates: How to Plan Your Cutoffs
15
Synchronize DSUR data, OLE updates, and narratives so you’re not scrambling post-filing.
Global Strategy: Aligning FDA & EMA When Endpoints Differ
22
Practical steps for minimizing divergence when agencies view your endpoints differently.
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