Vigilance Services
PharmExpert LLC provides pharmacovigilance consulting services to its clients in line with a global, regional and local levels PV guidelines/Good Pharmacovigilance Practices (GVP). Marketing authorization holders/Pharmacovigilance providers may delegate following services to Us:
– Development and maintenance of Pharmacovigilance System Master File (PSMF)
– Appointment of QPPV (Qualified Person responsible for PV) and QPPV back-up
– Weekly monitoring of scientific-medical literature, non-medical sources, internet or digital media for safety information search
– Collection, processing and reporting of Adverse Events (AE) and other safety related information from any sources
– Analysis, evaluation and storage of all reports of AEs
– Assessment of the benefit-risk ratio of the MP
– Development of aggregate reports: Periodic Safety Update Reports (PSUR), Development Safety Update Report (DSUR)
– Development of Risk Management Plan (RMP)
– Development and conduction of trainings on PV
– Conduction of external audits
– Appointment of LPPV (Local Person for Pharmacovigilance) and LPPV back-up in the MP’s authorization countries
– Safety database maintenance
– Weekly regulatory intelligence monitoring of Health and Regulatory Authorities for safety information and regulatory updates
– Conducting post-authorization safety studies (PASS)
– Interaction with regulatory authorities on drug safety issues
– Consulting services on issues in the field of PV
– Obtaining, processing and reporting information on safety in PASS
– Outsourcing of entire Pharmacovigilance System.
Materiovigilance deals with the identification, collection, reporting, estimating the undesirable occurrence and the possible management of adverse events associated with the use of medical devices, thus promoting patient health by preventing its recurrences.
PharmExpert offers in this field following services:
– Collection, investigation, and assessment of Adverse Device Effects (ADE) / Medical Device Incidents (MDI)
– Submission of Adverse Device Effects (ADE) / Medical Device Incidents (MDI) to manufacturer
– Monthly compliance and status reporting
– ADE and MDI Reconciliation
– Preparation of Periodic Summary Reporting
– Preparation of Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN)
– Periodic literature search in scientific literature to identify safety information and adverse reactions of products.
Nutravigilance refers to the science and activities relating to the detection, assessment, understanding and prevention of adverse events related to the use of a food, dietary supplement, or medical food.
List of services:
– Appointment of Local Contact Person for Food Supplement Vigilance
– Comprehensive management of adverse events of food supplements reported by consumers, health professionals or authorities
– Submission of serious adverse reactions to the manufacturer
– Periodic search of safety information of food supplement products in scientific literature
– Food supplement Product Safety Report
– Signal Detection and Management.
Cosmetovigilance is the ongoing and systematic monitoring of the safety of cosmetics in terms of human health. The aim is to detect adverse events of cosmetic products, and to prevent adverse effects by taking appropriate measures.
List of services:
– Appointment of Local Contact Person for Cosmetovigilance
– Comprehensive management of adverse events of cosmetic reported by consumers, health professionals or authorities
– Submission of serious adverse reactions to the manufacturer
– Periodic literature search in scientific literature to identify safety information and adverse events of cosmetic products
– Cosmetic Product Safety Report
– Signal Detection and Management.
Veterinary Pharmacovigilance is defined an activity to continuous safety monitoring by identifying and analysing any negative effects from the use of veterinary medicines that may occur in animals.
List of services:
– Appointment of Local Contact Person for veterinary medicines
– Comprehensive management of adverse events of veterinary medicines reported by consumers, health professionals
– Submission of serious adverse reactions to the manufacturer
– Periodic search of safety information of veterinary medicines in scientific literature
– Signal Detection and Management.
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Our Core Values
We care for our clients’ business as our business. We think and act like business partners, not academic advisors. We share our clients’ aspirations, work to understand their reality, and align our incentives with their objectives — so they know we’re in this together.
Public Health
We are a company that protects patients and consumers from the adverse drug reactions.
Customer satisfaction
We are a company that designs and builds client loyalty by meeting or exceeding our customer expectations and contractual obligations.
Quality Services on Pharmacovigilance
We are a company that provides adequate, reliable and regulatory compliance services.
Innovation Solutions
We are a company that creates and uses new ideas and methods.
Continuous Improvements
We are a company that optimizes the performance of our business and pharmacovigilance processes by maintaining continuous improvement of Quality Management System.
Staff training and development
We are a company that effectively addresses and satisfies any existing and projected needs of education, training and professional development of employees and other stakeholders of the Company.