Ethicare Pharmacovigilance is uniquely focused on providing comprehensive and customized pharmacovigilance (PV) services and offering specialized services to augment or support any drug safety department, tailored to fit your needs.
As a specialist PV service provider, Ethicare guarantee its clients about compliance, conformity, continuity and reliability. Ethicare always adhere to the highest quality standards, with a robust quality management system and corrective action and preventive action (CAPA) management process. Always in line with regulatory documents, such as GVP modules, and with a fully defined disaster recovery and business continuity plan in Place. Ethicare’s Client can only rest assured that they have chosen the best PV service provider.
Ethicare Provides Comprehensive Pharmacovigilance Drug Safety Services to pharmaceutical, biologic, innovator and generic product companies. All documentations are in accordance with FDA, ICH, CIOMS and GCP standards and guidelines.
At Ethicare, we offer end-to-end Pharmacovigilance (PV) solutions designed to meet evolving global regulatory demands. Our services are built on quality, integrity, and efficiency—enabling life sciences companies to maintain inspection-readiness, ensure compliance, and safeguard patient health.
All services listed below are aligned with applicable regulatory requirements of the European Union (EU), United States (US FDA), and India (CDSCO/PvPI/DCGI). We also support the set-up and customization of services in accordance with the requirements of any other applicable national or regional regulatory authorities, ensuring full compliance with jurisdiction-specific modifications wherever needed.
Establishment of fully compliant Pharmacovigilance systems including Vaccine Vigilance and Materiovigilance (Mv) tailored to product portfolio, regulatory jurisdiction, and market scope.
Comprehensive surveillance of indexed and grey literature in alignment with local and international regulations to detect, assess, and manage safety signals effectively.
End-to-end case management: Case Receipt, Triage, Data Entry (DE), Medical Review (MR), Quality Review (QR), and Regulatory Submission
Sources include: Spontaneous reports, Literature cases, Clinical trials, Patient Support Programs (PSPs), Market Research Programs (MRPs), Solicited/Unsolicited communications, Social media, and Partner/affiliate reports
Cross-reporting and regulatory submissions across global authorities with automated compliance checks and expedited timelines
Responsive, accurate, and regulatory-aligned handling of medical inquiries and scientific response documentation—ensuring consistency, audit readiness, and customer trust.
Preparation and quality-assured submission of key reports including:
PADER (Periodic Adverse Drug Experience Report),
PBRER/PSUR (Periodic Benefit-Risk Evaluation Report / Periodic Safety Update Report),
ASR/IRSR (Annual Safety Report / Investigational Report),
PPR (Product Performance Report for devices)
Structured signal detection, validation, prioritization, assessment, and tracking using both quantitative and qualitative methodologies in alignment with GVP Module IX.
Real-time safety surveillance throughout the clinical development lifecycle, including SUSAR management, DSUR preparation, and sponsor-investigator communication.
Design, implementation, and maintenance of Risk Management Plans (RMPs), REMS, and RMMs, customized per market and product profile.
Creation and maintenance of region-specific PSMFs- EU, UK, and global versions – ensuring traceability, version control, and regulatory alignment.
Data entry and lifecycle maintenance in the Extended EudraVigilance Medicinal Product Dictionary, ensuring compliance with EMA standards for centrally and nationally authorized products.
Drafting, negotiation, and maintenance of SDEAs with robust reconciliation processes to ensure partner compliance, audit-readiness, and oversight.
Drafting, negotiation, and maintenance of SDEAs with robust reconciliation processes to ensure partner compliance, audit-readiness, and oversight.
Internal audits, CAPA management, deviation handling, KPI monitoring, and continuous training – built to ensure system integrity and regulatory readiness.
Consultation and drafting assistance for client-specific SOPs to ensure alignment with global pharmacovigilance best practices and regulatory obligations.
Dedicated support for FDA, EMA, MHRA, Health Canada, and PvPI-CDSCO inspections—including mock audits, gap assessments, and audit remediation strategies.
Provision of Global Qualified Person for Pharmacovigilance (QPPV) services with 24/7 oversight responsibility and regulatory authority engagement and support for EU QPPV.
Oversight and coordination of local affiliate PV activities to ensure compliance with corporate SOPs and regional regulatory expectations.
With a dynamic Quality Management System (QMS), a fully traceable CAPA and Deviation Management System, and PV teams trained on inspection readiness and documentation best practices, we have established a proven track record of 20+ successful regulatory inspections; including US FDA (9), Kazakhstan Regulatory Authority (4), TGA – Australia (2), CDSCO – India (2), DCGI – India (1), Health Canada (1), WHO (1), and AMRH – Africa (1). Additionally, we have successfully cleared 30+ sponsor and CRO audits across global service lines, consistently demonstrating operational excellence and compliance leadership.)
