Strategic Partnering
Building and Negotiating Strategic Alliances
Strategic Advisor
- Weekly senior‑level guidance
- Regulatory intelligence updates
- Rapid Q&A support
Submission Partner
- Hands‑on IND/CTA/NDA/BLA/MAA build
- Authoring & QC for Modules 2 & 5
- Agency meeting preparation
Project/Hourly
- Briefing packages & responses
- Gap analyses & roadmaps
- Targeted deliverables
Navigating today’s complex global regulatory landscape requires insight, precision, and proactive planning. PrimePath Regulatory delivers integrated Regulatory Affairs Strategy and Operations support to ensure compliance, accelerate approvals, and strengthen your product’s development trajectory. From early development through post-approval maintenance, we provide customized solutions — including strategic guidance, submission planning, and hands-on regulatory operations — to help you anticipate challenges, engage effectively with global health authorities, and achieve timely, successful outcomes.
Strategy, Leadership, and Support
Global Regulatory Strategy & Submission Expertise
Global Regulatory Strategy
- US FDA, EMA, PMDA, NMPA, & ROW
- Program design & pathway selection
- Orphan & expedited programs (Priority Review, Fast Track, PRIME)
Submission Leadership
- IND/CTA/NDA/BLA/MAA planning & authoring
- Gap analyses & risk mitigation (avoid RTF/CRL)
- Briefing packages & agency meetings
Operational Support
- Labeling & COA evidence dossiers
- Expanded access & continuity of care
- Cross‑functional leadership (Clinical, CMC, Safety)
Global Regulations and Guidance
Short takes on evolving regulations, guidance, and submission best practices.
Avoiding RTFs: Top 5 Technical Pitfalls Before You File
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
Synchronize DSUR data, OLE updates, and narratives so you’re not scrambling post-filing.
Global Strategy: Aligning FDA & EMA When Endpoints Differ
Practical steps for minimizing divergence when agencies view your endpoints differently.
