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Welcome
Atessia Vigilances
Pharmacovigilance & Health Surveillance Solutions
Pharmacovigilance & Health Surveillance Solutions
Atessia Vigilances specializes in the regulatory and operational management of French and European health vigilance activities, including pharmacovigilance, medical device vigilance, in vitro diagnostic vigilance, haemovigilance, nutrivigilance, and cosmetovigilance.
We support stakeholders in the pharmaceutical industry, medical device, cosmetics, and other healthcare product sectors, ensuring compliance with the applicable regulations and requirements set by health authorities.
Atessia Vigilances :
A trusted partner for compliance throughout the entire lifecycle of your healthcare products.
Expertise
A team of pharmacists and scientists with expertise in health vigilance.
Vision
Our teams take a holistic view, with an integrated approach to safety, quality, and compliance.
Inspection-Ready
A robust and auditable process that meets health authority requirements.
Agility
A responsive organization capable of adapting to each request based on your specific needs.
Our services
Clinical trials
Pharmacovigilance for your clinical trials in Phase II, III, and IV, in line with health authority requirements before marketing authorization and throughout the post-authorization period.
Pharmacovigilance Monitoring
Regulatory and literature monitoring (local and/or international literature) for medicinal products.
EU-QPPV & RPV
Support in the development and/or restructuring of your pharmacovigilance (PV) system. Provision of European QPPV services or acting as the French Pharmacovigilance Responsible Person (RPV).
Case Management and Regulatory Reporting
Management of your cases in a pharmacovigilance (PV) database and in EudraVigilance for France and Europe. Preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). Ensuring the security of marketing authorizations (MAs) and the compliance of regulatory dossiers for your medicinal products.
24/7 On-Call Support and Medical Information
On-call and telephone support services. Comprehensive Level 1 and Level 2 medical information services, including adverse event management and patient safety.
Quality Audits and Pharmacovigilance Training
Design and conduct of pharmacovigilance audits for your departments, distributors, or partners. Tailor-made training programs in pharmacovigilance and medical information.
Medical Device Vigilance
Tailored services for manufacturers and distributors of medical devices for the management of incidents and adverse events, in compliance with health authority requirements.
Cosmetovigilance
Support in managing adverse events associated with cosmetic products, ensuring patient safety and compliance with standards set by health authorities.
Nutrivigilance
Consulting and support to ensure your nutritional healthcare products comply with nutrivigilance requirements.
What drives us to grow every day:
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Let's discuss your needs
Let us guide you through your projects. We will provide tailored solutions to build a long-term partnership.