Expert ICSR case processing and management services ensuring accurate, timely adverse event reporting and full regulatory compliance.
High-quality medical writing for PSURs, DSURs, RMPs, and regulatory submissions with scientific accuracy and compliance focus.
Strategic pharmacovigilance consulting for regulatory compliance, system setup, audits, and risk management across global.
Comprehensive PV quality assurance and compliance services to meet FDA, EMA, and global regulatory standards with zero tolerance.
End-to-end clinical safety management ensuring patient safety, protocol compliance, and robust drug safety monitoring during trials.
Proactive signal detection, evaluation, and risk management services to identify and mitigate drug safety issues effectively.
Design, development, and implementation of robust pharmacovigilance systems and safety databases for global compliance.
Streamlined adverse event intake and triage services with 24/7 support for fast and accurate safety data collection.
Local QPPV and country-specific pharmacovigilance services ensuring compliance in USA, India, and other key markets.
Full medical device vigilance and materiovigilance services for post-market safety monitoring and regulatory reporting.
Professional medical information call center providing accurate, timely responses to healthcare professionals and patients.
Cost-effective pharmacovigilance outsourcing services with end-to-end drug safety solutions for US and global pharmaceutical companies.
We used Atvigilx’s safety monitoring service and I appreciate their thoroughness. Their team delivered 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 team. Their 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 team’s 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 team and expertise in case processing. We successfully met tight deadlines thanks to 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 team showed expertise in signal detection and aggregate reporting. We successfully improved our safety timelines with support and proactive recommendations. I appreciate their responsiveness, thank you.
-QA Manager, Thailand
We engaged Atvigilx for device vigilance services and I appreciate the team’s pragmatic approach. Their 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 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…