Atvigilx
Atvigilx is a comprehensive provider of pharmacovigilance, regulatory affairs, and GCP services, with a focus on ensuring compliance, safety, and efficacy in pharmaceutical products. They serve clients in the USA, India, Australia, and Europe, offering tailored solutions across the entire product lifecycle, including drug safety monitoring, regulatory submissions, clinical trial oversight, and risk management. Their mission is to safeguard public health through meticulous safety monitoring, regulatory compliance, and innovative solutions, fostering trust and confidence in healthcare products.
Industries
Nr. of Employees
small (1-50)
Services
End-to-end PV service offerings including case processing, medical review, signal detection, risk management and regulatory reporting.
Regulatory strategy, dossier preparation, submission coordination and responses to regulatory authorities across multiple jurisdictions.
Conversion, compilation and publishing of regulatory documents in eCTD format with submission tracking and oversight.
GCP audits, site and study monitoring, inspection readiness and clinical trial quality assurance.
Design and implementation of pharmacovigilance quality management systems, SOPs, compliance monitoring and audit support.
Preparation of clinical study reports, aggregate safety reports, PSMFs, risk management plans and other regulatory documents.
End-to-end PV service offerings including case processing, medical review, signal detection, risk management and regulatory reporting.
Regulatory strategy, dossier preparation, submission coordination and responses to regulatory authorities across multiple jurisdictions.
Conversion, compilation and publishing of regulatory documents in eCTD format with submission tracking and oversight.
GCP audits, site and study monitoring, inspection readiness and clinical trial quality assurance.
Design and implementation of pharmacovigilance quality management systems, SOPs, compliance monitoring and audit support.
Preparation of clinical study reports, aggregate safety reports, PSMFs, risk management plans and other regulatory documents.
Expertise Areas
- Pharmacovigilance and safety surveillance
- Regulatory affairs and submission strategy
- Good Clinical Practice (GCP) compliance and auditing
- Safety signal detection and risk management
Key Technologies
- Electronic Common Technical Document (eCTD) publishing
- ICSR management systems
- Automated adverse event reporting
- Signal detection statistical methods
News & Updates
Presence in the USA and India.
Contact information including email and RFP/RFI link.
Highlighting decades of experience and global expertise in pharmacovigilance, regulatory affairs, and GCP services.
Presence in the USA and India.
Contact information including email and RFP/RFI link.
Highlighting decades of experience and global expertise in pharmacovigilance, regulatory affairs, and GCP services.