Atessia vigilances
Solutions in Pharmacovigilance and Health Vigilances
Expert firm specialized in the regulatory and operational management of French and European health vigilances: pharmacovigilance, materiovigilance, hemovigilance, nutrivigilance, cosmetovigilance.
We support stakeholders in the pharmaceutical industry, medical devices, cosmetics, and other health products, in compliance with current regulations imposed by health authorities.
Atessia Vigilances' Expertise
Case Management and Regulatory Reports
Handling of your cases in a pharmacovigilance (PV) database and in EudraVigilance for France and Europe. Writing periodic safety update reports (PSURs) and risk management plans (RMPs). We contribute to securing marketing authorizations (MA) and compliance of dossiers for your medicinal products.
24/7 On-Call and Medical Information
On-call service and telephone hotline. Provision of comprehensive level 1 and 2 medical information services, including adverse event management and patient safety.
Quality Audit and Pharmacovigilance Training
Design and conduct of pharmacovigilance audits for your services, distributors, or partners. Tailor-made personalized training programs in pharmacovigilance and medical information.
Clinical Trials
Pharmacovigilance for phase II, III, and IV clinical trials, in line with the expectations of health authorities before and after marketing authorization (MA).
Pharmacovigilance Monitoring
Regulatory and bibliographic monitoring (local and/or international literature) of medicines.
Pharmacovigilance System & EU-QPPV / RPV
Support in the development and/or restructuring of your PV system (SOPs). Fulfillment of the role of
European QPPV or French pharmacovigilance reference person (RPV).
Materiovigilance & Reactovigilance
Services tailored to manufacturers and distributors of medical devices for the management of incidents and adverse events, in compliance with the expectations of health authorities.
Nutrivigilance
Consulting and support for bringing your nutritional health products (e.g. food supplements) into compliance with nutrivigilance requirements.
Cosmetovigilance
Support in managing adverse effects related to cosmetics, to ensure patient safety and compliance with standards defined by health authorities.
Our Strengths
- A team of experts in health vigilances with a commitment to quality
- An agile and responsive structure, able to adapt to any type of request, depending on the products (medicines, medical devices, cosmetics, etc.) and the need (pharmacovigilance management, literature monitoring, procedures, compliance audit, etc.)
- A human and personalized approach, for supportive and tailored client service
TELL US ABOUT YOU AND YOUR EXPECTATIONS
Let us guide you in your projects.
We will offer you solutions for sustainable collaboration.
