Cosmetovigilance
Cosmetovigilance
Strengthen the Safety Monitoring of Your Cosmetic Products and Regulatory Compliance
In a context of increasing health vigilance requirements and evolving regulatory expectations, manufacturers, distributors, and Responsible Persons must ensure the safety of cosmetic products throughout their entire lifecycle.
Cosmetovigilance has become a strategic challenge to:
– detect and assess undesirable effects associated with cosmetic products
– ensure consumer safety
– comply with competent authority requirements
– strengthen post-marketing surveillance activities
– sustainably protect brand reputation and regulatory compliance
Atessia Vigilances supports cosmetic industry stakeholders in the implementation, management, and optimization of cosmetovigilance systems across France and Europe.
Our objective: to strengthen the safety of your cosmetic products, secure your regulatory obligations, and ensure effective monitoring of health-related risks.
Expertise Dedicated to Cosmetic Product Safety
Regulatory requirements applicable to cosmetic products require continuous monitoring of undesirable effects and safety data in order to ensure consumer protection.
Atessia Vigilances provides an integrated approach covering:
- management of undesirable effects
- safety data monitoring
- regulatory compliance
- support for cosmetovigilance obligations
- security of post-marketing surveillance activities
A pragmatic and structured approach tailored to the challenges of the cosmetic industry.
Undesirable Effect Management
The collection and assessment of undesirable effects are key pillars of any cosmetovigilance system.
Our teams manage:
- intake and registration of safety reports
- assessment of undesirable effects and serious undesirable effects (SUEs)
- follow-up of additional information requests
- centralization of consumer and healthcare professional data
- quality control of collected information
- full traceability of vigilance activities
Reliable processes designed to ensure consistency, responsiveness, and regulatory compliance.
Regulatory Reporting & Compliance
Serious undesirable effects must be reported to competent authorities in accordance with European regulatory requirements.
Atessia Vigilances supports clients with:
- cosmetovigilance regulatory reporting
- interactions with health authorities
- monitoring of European regulatory obligations
- regulatory impact assessments
- management of reporting timelines
Regulatory expertise designed to reduce compliance risks and secure your health vigilance obligations.
Post-Marketing Surveillance
Post-market surveillance enables early identification of potential risks and continuous monitoring of cosmetic product safety profiles.
Our experts support:
- collection and analysis of field safety data
- monitoring of trends and emerging signals
- assessment of product safety profiles
- evaluation of at-risk populations
- support to quality and regulatory teams
A proactive surveillance approach designed to strengthen consumer safety and protect your brands.
Quality Complaint Management
Quality complaints and consumer feedback represent critical sources of safety information.
Atessia Vigilances supports you with:
- product complaint management
- assessment of events potentially related to product safety
- quality trend analysis
- coordination with quality and regulatory teams
- follow-up of corrective and preventive actions (CAPAs)
A structured management approach to field data designed to strengthen post-marketing surveillance activities.
Cosmetovigilance & Inspection Readiness
Health authorities increasingly focus on the robustness of surveillance systems and the traceability of cosmetovigilance activities.
Atessia Vigilances supports organizations in:
- structuring cosmetovigilance systems
- drafting procedures and workflows
- quality audits and compliance assessments
- preparation for inspections and regulatory controls
- gap assessments and CAPA plans
Systems designed to be compliant, robust, and inspection-ready.
Team Training & Regulatory Awareness
Strong knowledge of regulatory requirements and cosmetovigilance best practices is essential to ensure organizational compliance.
We provide tailored training programs for:
- quality teams
- regulatory affairs teams
- consumer service departments
- vigilance and product safety teams
- manufacturers and distributors
Our programs cover:
- cosmetovigilance fundamentals
- undesirable effect management
- European regulatory obligations
- post-marketing surveillance
- documentation and quality best practices
Operational training programs designed to sustainably strengthen compliance and regulatory oversight capabilities.
An Integrated Quality Approach
Our cosmetovigilance activities are integrated into a structured quality framework tailored to cosmetic industry requirements.
We ensure:
- documented and auditable procedures
- full activity traceability
- robust methodologies
- appropriate quality controls
- risk-based approaches
An organization designed to sustainably secure your health vigilance activities.
Why Choose Atessia Vigilances?
Recognized Expertise in Regulatory Vigilance
Experienced consultants specialized in health safety, cosmetovigilance, and regulatory compliance.
Strong Knowledge of French and European Requirements
Compliance with health authority expectations and European cosmetic regulations.
A Pragmatic and Operational Approach
Solutions tailored to the operational realities of the cosmetic industry.
An Inspection-Ready Mindset
Systems and processes designed to support audits and regulatory inspections.
Flexible and Tailored Solutions
Full outsourcing, targeted support, or strategic consulting according to your needs.
What You Gain by Working with Us
– Strengthened cosmetic product safety
– Reduced regulatory risk
– Enhanced post-marketing surveillance
– Secured health vigilance data
– Improved preparedness for audits and regulatory inspections
Looking for an Expert Partner in Cosmetovigilance?
Atessia Vigilances supports cosmetic industry stakeholders in structuring, managing, and securing cosmetovigilance and post-marketing surveillance activities.