Trilogy Writing & Consulting


Trilogy Writing is a medical writing consultancy focused specifically on clinical regulatory and safety documentation. We work as an outsourcing partner for pharmaceutical companies of all sizes: proactively planning, coordinating and writing their clinical and safety documentation to meet timelines, with a readability that reduces the time for review and approval.
Beside regulatory submission documents, we also write Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMPs), including Part VI.