A FEW WORDS…
Vigilance: In a constantly evolving regulatory environment, experts in all types of vigilance (medicinal products, medical devices, food supplements, cosmetics) for your clinical trials and after marketing authorisation.
- Pharmacovigilance, Materiovigilance, Cosmetovigilance, Nutrivigilance
- Pre- & Post-Marketing Case Management
- Periodic Safety reports (PBRER/PSUR, DSUR…)
- Global & Local literature screening
- Signal Detection & Risk Management
OUR DELIVERY METHODS
AREAS OF EXPERTISE
We offer companies involved in pharmaceuticals and biotechnology, medicines, medical devices, food supplements and cosmetics, full coverage of pre- and post-market vigilance (incl. Phase I to IV clinical trials, Compassionate Use Programs and post-MA studies) in a wide range of therapeutic areas.
With our network of locations, we have the ability to set up a “full service” vigilance system.
We work closely with our clients to ensure that the services are provided optimally and meet their strategic and operational needs.
To ensure product safety and regulatory compliance, we offer:
- A high level of expertise
- Systematic medical analysis
- A continuous evaluation of the benefit/risk ratio of the product
- Rigorous quality assurance that safeguards the process
- Focus on compliance
- Organisational skills
- A range of technical solutions
- Communication skills
We can take charge of the vigilance of your products with the pharmacovigilance/materiovigilance/cosmetovigilance/nutrivigilance system set-up, including:
- EU QPPV and local QPPV responsibilities
- Pharmacovigilance System Master File (PSMF)
- Safety Data Exchanges Agreements (SDEAs)
- Procedures and instructions
- Safety database management (all vigilances)
- Preparation for audits and inspections
- Management of CAPAs
- EudraVigilance registration
Our vigilance organisation includes all the stakeholders, tools and procedures to optimally conduct operational activities:
*From reception to submission to Eudravigilance and authorities, incl. medical assessment, MedDRA coding, narratives writing. Knowledge of Safety Easy®, ArisG®, ARGUS® databases.
Focused on the quality of deliverables and the respect of deadlines, our highly qualified team of Vigilance specialists collaborates closely to provide the expected standard of expertise. Your projects are supervised by dedicated and experienced team members (Vigilance Officers and Vigilance Physicians). Your safety data are by medically assessed by medically qualified persons.