Our Services
(Supporting our customers through all stages of the product life-cycle)
YAQAZA offers a fully compliant and high-quality complete package of pharmacovigilance and materiovigilance services, tailored to meet your specific needs.
PV System Outsourcing
PV Consultancy
PV Training
Materiovigilance services
PV System Outsourcing
Pharmacovigilance is the science & activities relating to Detection, Assessment, Understanding and Prevention of adverse effects or any other medicine related problem.
Provided services by YAQAZA:
- Pharmacovigilance System Master File (PSMF)
- Standard Operating Procedures (SOPs)
- Management of Individual Case Safety Reports (ICSR)
- Preparation of all related PV reports (RMP, PBRER & ACO)
- Literature search & review
- Development of educational materials for risk minimization and creation of targeted questionnaires for specific patient groups, AEs or other safety concerns
- Conducting on-site or remote audits of internal and affiliate PV departments; as well as audits of contractual partners.
- Benefit-risk communications with competent authorities
- Quality Assurance Services
- Licensing agreements & monthly reconciliation with third parties
- Leaflets Translation and Medical Writing
- Pharmacovigilance Safety Database (Hyperlinked to VigiLink)
PV Consultancy
We can provide guidance and support in the development of the pharmacovigilance system undertaken within your organization in the following areas:.
- Development of SOPs, templates & working instructions supporting the PV activities
- PV Audit
- Training for PV & non-PV staff
- Literature screening
- PV safety database
- Development of educational materials for risk minimization
- Creation of targeted questionnaires for specific patient groups, AEs or other safety concerns.
PV Training
Join our advanced PV course and earn your certificate in Pharmacovigilance to start and advance your future career in PV and Drug Safety field.
Materiovigilance services
Medical device vigilance, known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Its primary purpose is to protect and improve safeguards for patients, users and others by preventing or reducing the likelihood of reoccurrence of incidents elsewhere.
Medical Device Vigilance Services:
- Medical Vigilance & Quality Assurance system including SOP development.
- Distribution of Field Safety Notices (FSNs) for medical devices.
- Applying Field Safety Corrective Actions (FSCAs) for medical devices.
- Adverse Device Effect (ADE) and Medical Device Incident (MDI) case processing, coding and follow-up.
- Submission of Incident reports (IRs) & Trend reports (TRs)for medical devices on timely manner.
- Literature search and review.
- ADE and MDI reconciliation.
- Periodic reporting: Periodic Summary Reports (PSRs), Periodic Safety Update Reports (PSURs) and Post Market Surveillance Reports (PMSR).
