Medical writing
Qinecsa provides crucial expert medical writing services to ensure accurate reflection of safety profiles for commercial and clinical products.
Our scientists and physicians generate expert reports to support regulatory submissions across the development lifecycle.
Succinct conclusions
Generate and maintain an accurate reflection of safety profiles across multiple data sources.
Ensure compliance
Seamlessly incorporate both internal requirements and regulatory commitments into reports.
Manage multiple stakeholders
Ensure all stakeholders are clear on roles and responsibilities early in the process to streamline submission.
Unrivalled medical writing services
Experienced drug safety writers
High-quality generation of global safety reports including aggregate reports, RMPs, line listings, protocol review, and interim safety analysis.
Technology-enabled
Management of each report through proprietary electronic document management review systems to ensure regulatory compliance.
Collaborative approach
Global stakeholder management, with agile teams working across all ICH regions.
Lifecycle management
Implementation and maintenance of end-to-end medical writing requirements.