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
Aggregate Reports
- Aggregate reporting with expert support.
- Experienced scientists and physicians writing.
- Benefit-risk management guarantees safety.
- Regulatory team ensures global readiness.
Protocol Review
- Global protocol review with expert support.
- Management, review, and scheduling.
- Expertise in protocol design and planning.
- Expert collaboration ensures resource optimization.
Risk Management Reports
- RMP preparation and submission formats supported
- Risk identification and management.
- REMS include goals and required activities.
- Version-controlled RMPs provided as single PDF.
Experienced Drug Safety Writers
- End-to-end medical writing lifecycle management.
- Agile teams across all ICH regions.
- Technology-enabled report management.
- Collaborative global stakeholder management.
Advancing Drug Safety Solutions to the Next Level
We’re working with life science companies to drive progress and continue protecting lives.
