From preclinical biotech to commercial medtech and investor storytelling, our clients trust us to deliver clarity, compliance, and outcomes – without the delays, handoffs, or compromises of larger agencies.
Below are anonymised and country-tagged success stories showing the speed, quality, and strategic impact we deliver across regulatory, medical affairs, market access, fundraising, and medcomms.
Example Case Studies
Across regulatory writing, medical strategy, safety reporting, and commercial content.
Biotech: Switzerland | Regulatory Writing & Submission Support
Challenge: Multiple modules, IBs, and briefing docs needed for EMA Solution: Delivered ready-to-submit content with no junior handoffs. Impact: Clean review cycles and confident regulator engagement.
and FDA alignment.
Biotech: USA | Full FDA Regulatory Suite Delivery
Challenge: Pre-BLA programme with multiple interlinked documents.
Solution: Delivered complete 2.7, 2.5, IBs, protocols, CSRs, and BBs.
Impact: Accelerated approval readiness.
Biotech: France | Global Safety & PV Documentation
Challenge: Safety deliverables required across several indications.
Solution: Delivered DSURs, PSURs, ICSRs, and narrative reports across agencies.
Impact: Maintained global compliance with zero queries.
Biotech: EU | Medical Communications for Launch Readiness
Challenge: Commercial decks and field materials needed for a high-profile product.
Solution: Delivered branded content, competitor analysis, and objection handlers.
Impact: Enabled clear HCP messaging and payer pull-through.
Biotech: USA | Diagnostics Market Support
Challenge: FDA tech content and education needed for a new diagnostic.
Solution: Created tech documentation, payer decks, and explainer tools.
Impact: Supported successful Dx launch and reimbursement discussions.