Let us focus on the technology while you focus on your core services
Our part of the PV Solutions, ProRelixResearch partners with advanced system to deliver hosting, implementation, system upgrades, technological support, and validation of the Argus Safety database.
We deliver a specialized safety environment, implementation experience, CFR 21 Part 11 compliance, proven audit track record, and safety service desk expertise.
A fully validated, 21CFR compliant safety database is an essential part of Good Pharmacovigilance Practice, whist efficient and accurate case processing is essential for fulfilling electronic ICSR reporting requirements, signal detection, and aggregate periodic safety reporting.
- Narrative writing
- Team of experienced Doctors for case and SAE narrative writing
- Risk management plan
- Expertise in risk analysis and management plan development and implementation
- Pharmacovigilance Master File
- Set up and implementation of Pharmacovigilance Master File
- Individual case safety reports writing
- Highly qualified and experienced recourses for Individual case safety reports writing.
- Individual case safety reports(Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR)/PBRER format, Periodic Adverse Drug Experience Reports (PADERs) ) submission
- Regulatory experts to prepare and submit the reports to the regulatory.
- Periodic Safety Update Reports writing and submission
- Expertise in PSUR writing and Submission