We support biotech, pharma, and medtech teams in navigating global regulatory pathways with clarity, speed, and senior-led strategy.
Our experience spans EMA, FDA, and other major regulatory bodies. Whether you're preparing a submission or seeking scientific advice, we help reduce risk and streamline timelines through proven expertise and efficient workflows.
Our Regulatory Affairs Services Include:
- Scientific advice briefing packages (EMA/FDA)
- Orphan Drug Designation (ODD) applications
- Regulatory roadmaps and pathway strategy (including PRIME, Fast Track, Breakthrough)
- Modules 2, 4, and 5 submission content, including summaries, study reports, and integrated documents
- Drafting, cross-document consistency, and version control using structured, tech-enabled workflows
- Global dossier tracking and lifecycle support
Case Studies
Biotech | Switzerland – Regulatory
Writing & Dual-Agency Submission Support
Challenge:
Compressed timelines for parallel EMA/FDA filings on a rare-disease programme,
with limited internal bandwidth.
Solution:
Embedded senior regulatory writers developed core CTD components (including
Module 2 summaries), coordinated inputs across functions, and aligned content
to agency expectations.
Impact:
On-time, submission-ready dossiers with clean review cycles, keeping regulatory milestones on track.
