Atvigilx provides end-to-end pharmacovigilance services, regulatory affairs support, medical writing, and drug safety solutions for pharmaceutical, biotechnology, CRO, medical device, and healthcare companies across the USA, Europe, Canada, and India.
We help organizations maintain FDA, EMA, CDSCO, MHRA, and Health Canada compliance through scalable pharmacovigilance outsourcing and regulatory support solutions designed to improve patient safety, operational efficiency, and global compliance.
Need expert pharmacovigilance support?
Our specialists help you manage safety monitoring, reporting, and regulatory compliance efficiently. Partner with us to ensure high-quality drug safety and risk management services.
Submit the form or contact our experts at info@atvigilx.com
Atvigilx is a specialized pharmacovigilance and regulatory affairs company delivering comprehensive drug safety services for pharmaceutical, biotechnology, healthcare, CRO, and medical device organizations worldwide.
Our experienced pharmacovigilance professionals support adverse event reporting, ICSR case processing, aggregate reporting, signal detection, SAE/SUSAR management, literature monitoring, medical writing, and global regulatory compliance activities aligned with FDA, EMA, CDSCO, MHRA, and Health Canada guidelines.
We provide scalable pharmacovigilance outsourcing solutions designed to help organizations reduce compliance burden, streamline safety operations, and maintain regulatory excellence throughout the product lifecycle.
Step 1 Safety Data Collection & Adverse Event Intake
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Step 2 Medical Review & MedDRA Coding
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Step 3 ICSR Processing & Quality Review
Step 4 Regulatory Submission & Reporting
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Step 5 Signal Detection & Risk Assessment
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Step 6 Continuous Compliance Monitoring
We used Atvigilx’s safety monitoring service and I appreciate their thoroughness. Their expert team delivered strong expertise in adverse event assessment and complaint handling. With on time support we successfully tightened our safety processes. Thank you for dependable service.
–Head of Safety & Compliance, Bulgaria
I engaged Atvigilx for clinical safety support and I appreciate their expert team. Their strong expertise in SAE reporting and protocol safety assessments was evident. We successfully met IRB and sponsor timelines because of prompt, on time support. Thank you for excellent service.
–Clinical Safety Coordinator, USA
I appreciate the expert team’s strong expertise in aggregate reports and CAPA management. With consistent on time support, we successfully passed regulatory inspections. Thank you, their service strengthened our PV system.
–PV Program Manager, India
We partnered with Atvigilx for pharmacovigilance services. I appreciate their expert team and strong expertise in case processing. We successfully met tight deadlines thanks to on time support and clear communication. Thank you, the service boosted our compliance confidence.
–Head of Pharmacovigilance, USA
As QA manager, I praise Atvigilx’s PV service. Their expert team showed strong expertise in signal detection and aggregate reporting. We successfully improved our safety timelines with on time support and proactive recommendations. I appreciate their responsiveness, thank you.
–QA Manager, Thailand
We engaged Atvigilx for device vigilance services and I appreciate the expert team’s pragmatic approach. Their strong expertise in regulatory submissions and on time support helped us close audit findings. We successfully maintained market access. Thank you for reliable service.
–Regulatory Affairs Lead, Poland
I recommend Atvigilx for pharmacovigilance operations. Their expert team brought strong expertise to ICSRs and quality systems. We successfully transitioned our PV processes with minimal disruption, supported by on time support and clear training. I appreciate their dedication.
–Safety Operations Director, Australia
Atvigilx specializes in Pharmacovigilance, Regulatory Affairs, and GCP Services, providing comprehensive support to ensure compliance…