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.
We support CMC strategy and regulatory documentation in close alignment with clinical development, regulatory submissions, and market readiness, working alongside specialist CMC teams where appropriate.
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
- CMC-related regulatory documentation and submission coordination (in collaboration with specialist CMC teams)
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.
