We provide medical & drug safety services to pharmaceutical companies across the globe. Our expert team consisting of senior advisors, physicians & Pharma covigilance professionals.
We offer end-to-end pharmacovigilance support for global pharmaceutical companies and clinical trials involving all therapeutic areas and to emerging pharmaceutical companies to develop and maintain their drug safety systems.
Providing high quality drug safety services to Pharmaceutical companies, Research organizations and health agencies.
Drug Safety Services
- End-to-end Case Processing (ICSRs) – case intake and triage, MedDRA coding, narrative writing and medical assessment
- Aggregate Reporting (PBRER/PSUR, PADER and DSUR)
- Preparation and submission of Periodic Safety Update Reports (PSURs) to Competent Authorities
- Writing of Risk Management Plans (RMP) / Risk Evaluation & Mitigation Strategies (REMS).
- Benefit-Risk assessment and communication to Regulatory Authorities and Healthcare Professionals
- Signal Detection & Management
- Preparation, review and approval of standard procedures for PV system
- Literature search
- Worldwide Literature screening through automated literature screening module
- Clinical Trial Safety Management
- Medical Information (including Call Centre Support)
- Regulatory Safety Assistance (pre & post-authorization)
- Standard Operating Procedures (SoPs), Working Instructions (WIs) & Guidance Assistance
- Audits & Inspection support
- Training & Consultancy
- Implementation of CAPAs
- Pharma covigilance System Master File (PSMF) Preparation
- Turnkey Projects in Pharma covigilance