Molecular Drug Safety Solutions
Revolutionary pharmacovigilance and drug safety services at the intersection of medicine and technology
Our Advanced Services
01
Core Services
Drug Safety
SAE and SUSAR Management
Medical Monitoring and Evaluation
Safety Management Plan (SMP) and Investigator Brochure (IB)
Protocol Review and Safety Input
Legal Representation in EU / Responsible Person in EudraVigilance
Sponsor Profile Registration in EudraVigilance
Pharmacovigilance
Medical review by board-certified physicians
EU and Local QPPV Services
ICSR Management & Medical Review
Signal Detection and Management (including EVDAS)
PSUR, RMP, and other safety reports
Pharmacovigilance System Master File (PSMF)
Safety Database Management
Medical Monitor Services
Scientific literature search and critical evaluation
Systematic bibliographic searches in biomedical databases
Critical review and summarization of scientific publications
Management of medical inquiries from healthcare professionals and patients
QPPV services
LPPV and (Deputy) EU QPPV Services
PV procedural document design/adaptation
Signal detection and risk management activities
Medical evaluation of Individual Case Safety Reports
Query and data extraction from safety databases
Post-marketing and clinical SAE triage
Subject narrative preparation for clinical study reports
Support for audits and inspections
Review and coordination of safety reports (PSURs, DSURs, RMPs, etc.)
Patient exposure calculation from shipment/IMS data
Global and local literature reviews
Study document review (protocols, CSR)
Representation in interdepartmental safety meetings
Quality services
Pharmacovigilance Audits
Quality Management and SOP Development
Our Advanced Services
We provide end-to-end drug safety and pharmacovigilance solutions to ensure compliance, patient safety, and regulatory success.
01
Core Services
Drug Safety
SAE and SUSAR Management
Medical Monitoring and Evaluation
Development Safety Update Reports (DSUR)
Investigator Brochure (IB)
Protocol Review and Safety Input
Regulatory Compliance
Legal Representation in EU
Responsible Person in EudraVigilance
Sponsor Profile Registration in EudraVigilance
02
Pharmacovigilance
Medical Review & Evaluation
Medical review by board-certified physicians
EU and Local QPPV Services
ICSR Management & Medical Review
Safety Reporting
Signal Detection and Management
EVDAS Implementation
PSUR, RMP, and other safety reports
Pharmacovigilance System Master File (PSMF)
Safety Database Management
Quality Management
Quality Management and SOP Development
Pharmacovigilance Audits
Quality Management Systems
03
Medical Services
Literature Review
Scientific literature search and critical evaluation
Medical review of promotional materials
Systematic bibliographic searches
Critical review of scientific publications
Medical Support
Management of medical inquiries from HCPs
Management of medical inquiries from patients
04
QPPV Services
Qualified Person Services
LPPV and (Deputy) EU QPPV Services
PV procedural document design/adaptation
Signal detection and risk management
Medical evaluation of ICSRs
Reporting & Documentation
Query and data extraction from safety databases
Post-marketing and clinical SAE triage
Subject narrative preparation for CSRs
Review and coordination of safety reports
Additional Services
Patient exposure calculation
Support for audits and inspections
Global and local literature reviews
Study document review
Representation in safety meetings
Our commitment to drug safety is unwavering, ensuring that every pharmaceutical product meets the highest standards of quality and patient protection.
— PharmaVigilance Team
Specialty Solutions
Additional specialized services to support your pharmaceutical needs
Drug Safety & Pharmacovigilance
Investor reports & due diligence services
Literature Reviews
Medical affairs support and KOL development & engagement
Literature Reviews
Clinical trial recruitment strategies
Literature Reviews
Epidemiology services
Investor Reports & Due Diligence
AI-powered investor reports
Tailored to your needs with validated information and timely delivery
Information Validation
Specialized physicians network for pharmacovigilance support.
Access to a global network of specialized physicians for pharmacovigilance support, including rapid SUSAR review (within 48 hours) and optimized safety strategies