Pharmacovigilance & Patient Safety
Commitment to continuous monitoring, rigorous quality standards, and transparent adverse event reporting across our global therapeutic portfolio.
Safety & Quality Framework
Our integrated pharmacovigilance system aligns with ICH-GVP guidelines and global regulatory expectations.
Pharmacovigilance (PV)
Continuous detection, assessment, and prevention of adverse effects through automated signal detection and medical review.
Clinical Trial Safety
Independent Data Safety Monitoring Boards (DSMBs), real-time SAE tracking, and protocol deviation management.
Manufacturing Quality (GMP)
Strict adherence to WHO/FDA GMP standards, batch record audits, environmental monitoring, and release testing.
Risk Management Plans
Proactive identification of safety signals, REMS program development, and periodic benefit-risk evaluations.
Post-Market Surveillance
Real-world evidence integration, literature screening, and cross-border regulatory reporting workflows.
Data Integrity & Compliance
ALCOA+ principles, audit trail maintenance, and validated PV database systems (Argus/ArisG).
Adverse Event Reporting Workflow
Standardized, secure, and regulatorily compliant process for healthcare professionals and patients.
Submit Report
Secure web portal, hotline, or regulatory email intake for AE/SAE data.
Medical Triage
24/7 qualified medical reviewers assess seriousness and urgency.
Coding & Analysis
MedDRA coding, causality assessment, and duplicate screening.
Regulatory Filing
Timely E2B(R3) submissions to FDA, EMA, and other competent authorities.
Regulatory Compliance & Certifications
Validated systems and accredited quality management across all therapeutic divisions.
U.S. Pharmacopeia Compliance
Current Good Manufacturing Practice (cGMP) certification
EU GVP Modules I-XIV
Full pharmacovigilance system master file (PSMF) alignment
ISO 13485 / 9001
Quality management for medical devices & pharma operations
Clinical & Preclinical Standards
ICH E6(R3) readiness and OECD GLP compliance
Report a Safety Concern
Healthcare professionals, patients, and caregivers can submit adverse event reports securely. All submissions are reviewed by licensed medical pharmacovigilance specialists.