We manage post-marketing and pre-marketing Pharmacovigilance activities for pharmaceutical companies that need complete and timely outsourced services to implement and maintain a pharmacovigilance system in accordance with the current legislation. We also take care of the vigilance on Medical Devices (Materiovigilance), Cosmetics (Cosmetovigilance) and Phytotherapy Products (Phytovigilance).
Pharmacovigilance outsourcing services
Pharmacovigilance services: together for the public health protection
Focus on regulatory compliance of interventional clinical trial
Our mission is to preserve the safety of patients involved in the clinical trials providing the compliance with the current legislation at every stage of Investigational Medicinal Product (IMP). With our expertise we manage each pharmacovigilance activity of interventional clinical trials starting from Standard Operating Procedure to SAE collection until to SUSAR and DSUR notification to Competent Authorities.
Regarding the clinical trials we support for:
- Standard Operating Procedure drafting and updating
- Safety Monitoring Plan drafting
- Eudravigilance management: EV Responsible Persone
- Adverse events collection, management and evaluation (AE, SAE)
- SUSAR notification to Competent Authorities
- Development Safety Update Report (DSUR) editing and notification to Competent Authorities
- Audit and Inspection preparation
MEDICAL DEVICE VIGILANCE
Materiovigilance: patient health and safety in the first place
The Materiovigilance is the framework that manage and control the proper functionality of medical devices and the detection and management of communications regarding alterations and incidents occurring after the marketing. The aim of the medical device vigilance is to guarantee health and security of patients and users. According to the current regulation, JSB experts collaborates with all the players involved in the process for the fulfilments required, managing the following activities on behalf of our clients:
- Standard Operating Procedures drafting and updating on Materiovigilance activities
- Support for manufacturers/and authorized representatives for the management and notification of Incidents (including the follow-up phase and any Corrective Actions) that occurred in EU and non-EU territory
- Support for manufacturers/ and authorized representatives for the management of post-market and pre-market clinical investigations
VIGILANCE ON COSMETICS
Cosmetovigilance: collecting and reporting of undesirable effects
We manage all the activities regarding the collection, casuality assessment, managing and monitoring of undesirable effect reports that arise from the use of cosmetics, with the aim of facilitating post-marketing surveillance and protecting the consumer health . As Responsible Person, we promptly identify the onset of problems relating to cosmetic products safety, managing, reporting and drafting Standard Operating Procedures on Cosmetovigilance activities, collecting and managing the reports, and the following notification to Competent Authorities and updating the Product Information File.