Case Studies

Global vaccine company needed comprehensive medical writing and regulatory documentation across multiple vaccine products for Phase 2 through Phase 3 transition.

Delivered integrated medical writing strategy spanning protocols, investigator brochures, study reports, and regulatory submissions across US, EU, and global markets.

Timely Phase 3 study initiation with successful regulatory document approvals across global jurisdictions including submissions to EU-CTR and CBER.

Precision medicine company faced payer resistance despite breakthrough clinical data for rare hematologic therapy.

Delivered integrated value communication strategy combining therapeutic expertise with market access intelligence.

Global value dossier acceptance with scalable communication framework across key markets.

A leading medtech company in spine and neurosurgery lacked a clear publication process, limited writing capacity, and needed to better connect clinical evidence with market access value.

We embedded specialists, built publication workflows, and aligned education programs with payer priorities—integrating communications, event insights, and faculty engagement into one streamlined approach.

A global communication framework was established, producing 18 publications and accelerating the reach of credible, consistent content that elevated both education and market access discussions worldwide.

Global pharmaceutical company needed comprehensive regulatory and HTA intelligence to optimize Phase 3 design for rare bleeding disorder therapy.

Integrated regulatory and HTA landscape analysis with strategic joint scientific advice preparation.

Successful joint EMA-HTA consultation strategy with comprehensive mock workshop delivery.