Our medical writing services include Investigator’s Brochures (IB), Clinical Performance Study Protocols (CPSP), and Clinical Performance Study Reports (CPSR). We also develop Performance Evaluation Reports (PER), conduct literature reviews, and prepare Post-Market Performance Follow-Up (PMPF) evaluation reports, Post-Market Surveillance Reports (PMSR), and Periodic Safety Update Reports (PSUR).

Our expert project management ensures seamless coordination and execution of clinical studies, from planning through completion, keeping timelines and budgets on track.

We specialize in the full spectrum of IVD clinical study services, from study design to execution and management. Our services include site selection, monitoring, and management, as well as coordinating the ethics approval process. We handle everything from regulatory submissions and investigator training to patient recruitment, ensuring compliance with regulatory standards while delivering high-quality clinical performance data to support regulatory submissions.

We compile and prepare the product dossier for regulatory submission, ensuring it meets the necessary standards for approval.

Our expertise extends to clinical development and post-marketing strategies, helping you optimize product lifecycle management and market success.