NutriVigSafe® is an organization-wide Quality Management System for the professional treatment of signal monitoring, safety and quality of nutraceuticals.
NutriVigSafe® offers companies the following services:
Nutrivigilance
Complaint treatment is divided into 2 categories:
- Adverse Events Complaints (AECs)
- Serious Adverse Events Complaints (SAECs).
All nutraceuticals can be incorporated into this nutrivigilance system.
NutriVigSafe® nutrivigilance system includes the safety monitoring of:
- Vitamins
- Minerals
- Botanicals
- Other substances
SERVICES OFFERED:
Assessment of Adverse Events Complaints/Serious (AEC/SAEC)
Analysis of Adverse Events Complaints/Serious (AEC/SAEC)
Reporting to the Company of the received Adverse Events Complaints/Serious (AEC/SAEC)
Draw up of Individual Case Safety Reports (ICSR)
Literature screening of overdose, adverse events, studies, toxicity, safety, lack of effectiveness, pregnancy, lactation
Draw up of Periodic Safety Update Report (PSUR)
Causality Assessment of the received of Adverse Events Complaints/Serious (AEC/SAEC)
Archiving of the nutrivigilance documents and files of your company
At the request of the company, of Adverse Events Complaints/Serious (AEC/SAEC) can be reported to the competent authorities.
QUALITY COMPLAINTS
NutriVigSafe® also offers the service of handling quality complaints related to nutraceuticals.
This handling of quality complaints includes:
Receiving and registering quality complaints
Assessment of quality complaints
Analysis of quality complaints
Reporting and discussing quality complaints
Treatment of quality complaints
PRODUCT SIGNAL DETECTION
Product signal detection includes:
- monitoring of raw materials used in nutraceuticals
- monitoring recent scientific publications of raw materials in the context of already existing fields of application.
- monitoring recent scientific publications of raw materials in the context of new application areas.
- monitoring recent scientific publications in the context of combinations of raw materials.
- monitoring new nutraceuticals worldwide
NutriVigSafe® offers companies, in function of a risk-based assessment, a choice from these three modules or a total package.
- NUTRIVIGILANCE
- QUALITY COMPLAINTS
- PRODUCT SIGNAL DETECTION
NutriVigSafe® provides a telephone number and email address that customers and health care professionals (HCP) can use to report complaints and adverse events. This telephone number and email address can also be mentioned on your website, on packaging and package leaflets for your nutraceuticals and for the B2C and B2B documents of your company.