Our Services
Revolutionary pharmacovigilance and drug safety services at the intersection of medicine and technology
Core Services
Drug Safety
Pharmacovigilance
Medical Monitor services
QPPV services
Quality services
Specialty Services
Investor reports & due diligence services
AI-powered investor reports
Specialized physicians network for pharmacovigilance support
Epidemiology services
Clinical trial recruitment strategies
Medical affairs support and KOL development & engagement
Specialty Services
Investor reports & due diligence services
AI-powered investor reports
Tailored to your needs with validated information and timely delivery
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
- Epidemiology services
- Clinical trial recruitment strategies
- Medical affairs support and KOL development & engagement
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
Our Pharmacovigilance services ensure continuous monitoring of the safety of medicinal products, from early development through post-marketing.
We support Marketing Authorisation Holders with robust safety operations, including case management, signal detection and evaluation, global literature monitoring, and the preparation of regulatory safety reports.
We provide flexible, reliable solutions tailored to each company’s needs, ensuring full compliance with EMA, FDA and international PV requirements. If your organisation is looking for expert support to strengthen its safety system, our team will be pleased to assist you.
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
LPPV and (Deputy) EU QPPV Services
PV procedural document design/adaptation
Medical evaluation of Individual Case Safety Reports
Subject narrative preparation for clinical study reports
Post-marketing and clinical SAE triage
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
Query and data extraction from safety databases
Signal detection and risk management activities
Pharmacovigilance Audits
Quality Management and SOP Development
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries
Tailored to your needs with validated information and timely delivery
Access to a global network of specialized physicians for pharmacovigilance support, including rapid SUSAR review (within 48 hours) and optimized safety strategies
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries
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