Clinical, Regulatory and Market Access/HEOR • Value Communications • Medical Communications and Education
Documentation for regulatory and health technology assessment (HTA) submissions, including clinical study protocols, clinical study reports, HTA materials, global value dossiers, and AMCP dossiers. Deliverables are structured to meet the requirements of regulatory agencies in the United States (FDA), European Union (EMA), and United Kingdom (MHRA), as well as HTA bodies and payers, ensuring scientific rigor, compliance, and clear communication of product value.
Development of global value dossiers (GVDs), value messages, value stories and propositions, payer value narratives (PVNs), core value slide decks, payer/KOL engagement slide decks, objection handlers, evidence gap analyses, unmet need assessments, disease/economic burden analyses and reports, and landscape analyses covering treatment, payer, and competitor perspectives.
Extensive portfolio across a wide range of deliverables and therapy areas