Pre- and Post-marketing integrated Pharmacovigilance services
Medical expertise provided by internal EU Qualified Person for Pharmacovigilance (EU QPPV)
Constant monitoring and evaluation of the Risk/Benefit ratio of the product.
Drug Safety and Pharmacovigilance Services
Preparation of customized drug safety and pharmacovigilance SOPs
Registration of Sponsors in the EMEA EudraVigilance database
Registration of medicinal products in the EVMPD
Third Party Service Provider as a service
Individual Case Safety Reports (ICSRs)
EVMPD information to EudraVigilance via EV WEB
SAE coding, management and Expedited reporting: Collection, Quality Control, Assessment, narrative writing, unblinding and management of ICSRs
Periodic Safety Reporting: clinical trials Annual Safety Reports, IND reports, EAP Periodic Safety Reports and PSURs
Preparation of MAA module 1.8.1 and 1.8.2: Risk Management Plans including Pharmacovigilance Plan, Pharmacovigilance System Description.
Participation in global safety meetings with the Competent Authorities
Review of safety sections of promotional material
Safety training of Medical Science Liaisons and Sales Teams.
Medical Device Vigilance Services
Pre and post-marketing vigilance services for all classes of Medical Devices according to the European guideline MEDDEV 2.12-1 rev. 5, including:
Preparation of customized Standard Operating Procedures (SOPs) for Medical Device Vigilance system and Incidents / Near Incidents reporting procedures.
Incidents/Near Incidents management: Cases reception, Quality Control Assessment, and preparation of narratives
Incidents / Near Incidents Expedited Reporting: Preparation and submission of Manufacturer Incident Reports and Field Safety Notice (FSN) to multiple Regulatory Authorities where necessary.
Periodic Vigilance Reports: Complete and submit Periodic Summary / Trend Reports to National Competent Authority
