Case Studies

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 that kept regulatory milestones on track.

Challenge: Medical Affairs required a clear scientific narrative and compliant materials to support launch readiness ahead of a high-profile product introduction.

Solution: Developed a scientific platform and non-promotional HCP materials, including data-driven decks and competitive landscape analysis, aligned to the latest evidence and medical governance requirements.

Impact: Clearer scientific communication with HCPs and improved cross-functional alignment across markets.

Challenge: Global team preparing for payer discussions needed HEOR-aligned value messaging and practical workshop tools.

Solution: Developed a value framework, payer-salient messages, and interactive workshop materials grounded in patient insight and evidence.

Impact: Stronger internal alignment and more confident HTA conversations across regions.

Challenge: A new entrant to oncology needed a cohesive value narrative and launch materials for multi-stakeholder education.

Solution: Refined brand and scientific storytelling; built cross-functional assets for field and digital channels with MLR-ready copy.

Impact: Faster stakeholder uptake and a consistent external story at launch.

Challenge: Pre-Series A company needed to convert strong science into a compelling, credible investor story.

Solution: Interviewed leadership, benchmarked peers, and created a crisp deck and capital narrative; coordinated warm introductions with investors, scheduled and facilitated investor calls, and represented the client through pre-, peri- and post-meeting discussions.

Impact: A sharper investment case, better-targeted outreach, and stronger investor engagement during the raise.