Audit-ready, scientifically sound, and submission-grade documentation designed to withstand rigorous scrutiny from global health authorities (US FDA, EMA, HSA).
Regulatory medical writing is not mere transcription; it is the strategic translation of complex clinical trial data into clear, persuasive, and strictly compliant narratives. A poorly structured protocol or an ambiguous Clinical Study Report (CSR) can trigger regulatory clinical holds, lengthy Information Requests (IRs), and delayed patient access.
At Kensai Health, our regulatory writing practice is directed by senior clinical specialists backed by over two decades of hands-on submission experience across global pharma and CROs. We combine rigorous ICH/GCP compliance with strategic narrative clarity to deliver first-pass regulatory acceptance.
Every regulatory document is authored, cross-verified against source data tables, and quality-controlled by senior writers. Zero junior delegation.
Scientifically robust, operationally viable protocols across Phases I to IV. We ensure design clarity, precise endpoint definitions (primary, secondary, exploratory), and realistic schedule of assessments to prevent costly site amendments.
Complete, abbreviated, and synoptic CSRs authored in full compliance with ICH E3 guidelines. Every efficacy and safety claim is 100% cross-checked against source TLFs, patient profiles, and EDC listings.
High-level strategic summaries for marketing authorization applications. We synthesize multi-study programs into cohesive, persuasive benefit-risk narratives for regulators.
Authoring initial first-in-human IBs and conducting rigorous annual developmental updates integrating new preclinical toxicology, safety pharmacology, and emerging clinical pharmacokinetic data.
Navigating the heightened evidentiary standards of EU MDR (2017/745). We author compliant Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Post-Market Clinical Follow-Up (PMCF) plans.
Patient engagement materials authored to strict international health literacy standards, ensuring cultural sensitivity and ethical compliance across diverse global trial sites.
A disciplined, milestone-driven workflow ensuring zero defects and rapid turnaround.
Annotated outline, template alignment, regulatory strategy agreement, and timeline sign-off.
Direct coordination with Biostats and DM vendors to verify SAP, Mock TLFs, and data integrity.
Senior authoring followed by independent 100% data audit against source statistical tables.
Chaired Comment Resolution Meetings to harmonize multi-stakeholder feedback harmoniously.
Final publishing, eCTD readiness check, electronic signatures, and health authority submission support.
