Submissions
ICSR submissions are sent electronically and, in some instances, manually across the globe. Qinecsa handles these submissions across all formats and modes, ensuring reliability as well as quick service, to ensure 100% regulatory and business partner compliance.
Reliable Submission Management and Reporting
Well-organised and compliant submissions are critical to robust Pharmacovigilance practices. Qinecsa’s submission services provide comprehensive support throughout the entire process to ensure that all regulatory requirements are met in a timely manner.
Our submission management processes are designed to integrate seamlessly with your existing systems, creating a unified approach and reducing administrative burden. By leveraging our expertise, organisations can achieve expedited services, faster turnaround, improved accuracy, and enhanced compliance across all submission types.
Extensive Submission Support
Effective submission management begins long before documents are prepared. Our strategic planning services help organisations develop submission roadmaps that align with broader business objectives. Qinecsa’s submission capabilities also span all types of formats and requirements. Our team provides expert handling of:
- Regulatory submissions across multiple jurisdictions
- Clinical trial documentation and results reporting
- Safety updates and periodic reports
- Post-marketing surveillance documentation
- Response to health authority inquiries and information requests
Through our technology-enabled processes, we ensure that each submission meets the specific requirements of relevant regulatory and partner compliance while maintaining consistency. At Qinecsa, quality is at the heart of every successful submission. Our team of specialists implements advanced quality control measures throughout the process to identify and address potential issues before they impact timelines.
Effortless data migration services facilitate a seamless transition while ensuring the integrity and performance of your data. A worry-free journey.
Expedited Reporting
Our regulatory experts verify the accuracy and completeness of the ICSR submission packages, ensure client reviews, and perform submissions through Gateways, health authority web-portals, eFax, emails and through postal submissions.
Business Partner Distributions
Based on the safety data exchange obligations (SDEA), our pharmacovigilance specialists distribute the pertinent ICSR packages to necessary third parties via Gateway and emails maintaining timeliness and quality of submissions.
Reconciliations
Based on SDEA obligations, periodic reconciliations are performed with partners to measure compliance. Regulatory and partner compliance metrics are tracked and reported to clients periodically to provide oversight.
Working with Qinecsa for Your Submission Needs
By entrusting Qinecsa with your submissions, you gain a partner committed to excellence at every stage — from initial planning through successful regulatory compliance. Our transparent communication and quality control processes keep you informed every step of the way, providing confidence that your submissions are in capable hands.
