Welcome to Neoteric Vigilcare
The Neotericvigilcare Advantage
Full-Service. High Quality. Maximum Efficiency.
At Neoteric vigilcare, we are committed to enhancing patient safety through robust pharmacovigilance system, experienced in drug safety and regulatory compliance, we partner with pharmaceutical, biotech, and medical device companies to ensure the highest standards of vigilance throughout a product’s lifecycle
- Individual Case Safety Report (ICSR) processing and submission
- Regulatory authority liaison and audit support
- Global pharmacovigilance outsourcing solutions
Why Choose Neoteric Vigilcare Solutions?
End-to-end PV services customized to your product needs
Compliance with global regulations (EMA, FDA, CDSCO, MHRA, PMDA, WHO)
Experienced team of PV professionals, QPPVs, and MDs
Real-time analytics and reporting tools for enhanced decision-making
Our Services
As a trusted CRO partner, we bring extensive expertise and industry knowledge in Pharmacovigilance (PV), ensuring the highest standards of patient safety and regulatory compliance throughout the product lifecycle.
ICSR Processing & Submission
End-to-end intake, triage, case processing, medical review, quality checks, and global electronic submissions.
Literature Surveillance & Medical Review
Global/local literature screening, relevancy assessment, and SME-backed medical review for safety signals.
Signal Detection & Risk Management
Quantitative/qualitative signal detection, validation, and risk minimization planning with periodic evaluation.
Periodic Safety Reports (PADERs, DSURs, PSURs)
Authoring, data synthesis, QC, and on-time submissions across regions and regulatory frameworks.
PSMF Creation & Maintenance
Compliant Pharmacovigilance System Master File setup, governance, annex management, and inspection readiness.
Regulatory Liaison & Audit Support
Health authority interface, CAPA management, readiness assessments, and end-to-end audit/inspection support.
Global PV Outsourcing Solutions
Flexible FSP and managed services models, multilingual teams, and 24/7 coverage to scale PV operations.
Narrative Writing
High-quality medical narratives for ICSRs and aggregate reports, ensuring clinical coherence, consistency, and regulatory-ready documentation.
Regulatory Submission
Preparation and on-time submission of ICSRs, PSURs/DSURs, RMPs, and supporting safety data per FDA/EMA/MHRA requirements and formats.
Medical Information Call Center (MICC)
24/7 multilingual MICC handling HCP/patient inquiries, AE/PQC intake, scientifically accurate responses, and seamless PV system integration.
Translation Services
End-to-end language solutions across 100+ languages, combining expert linguists and domain specialists to deliver accurate, culturally nuanced translations for documents, websites, software, and marketing content.
Clinical Trials
Comprehensive clinical research support from study design to submission, including protocol development, site management, patient recruitment, data management, biostatistics, and regulatory documentation
Quality
Quality is a culture at Aragen and we strive to exceed the expectations of our customers.
Discover Our Services
Keeping Medicines safe for Everyone
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Contact Us Today
Get In Touch With Us Us
Australia Address
53 east road Hocking 6065 Western Australia
India Address
Sector 66, GMADA Market, S.A.S Nagar (Mohali) 160062, Punjab
Phone Number
+911603577458 / +917837366123
Email Address
info@neotericvigilcare.com