Aggregate reports
Aggregate reports represent a consolidated overview and detailed assessment of a products’ benefit-risk profile. Qinecsa provides comprehensive end-to-end aggregate reporting management, supported by our team of experts, an array of specialized services and technology.
Comprehensive aggregate reporting management services, covering source data collation and review, report authoring, quality review, and medical review all designed to facilitate timely submissions to pertinent regulatory authorities.
Medical writing expertise
Our high caliber scientists and physicians are experienced across diverse therapeutic areas and therapy types across all phases of the drug development lifecycle.
Benefit-risk assessment
Benefit-risk management verifies that the benefits of a medication continue to outweigh the risks, ensuring patient safety with medicinal therapies.
Submission
Qinecsa regulatory team are supported by a wide network of consultants and vendor partner network for submission readiness for global agencies including US-FDA, EMA, and MHRA.