Secure Your Regulatory Obligations and Pharmacovigilance Governance


Pharmaceutical companies are facing:

• increasing EMA and ANSM requirements
• enhanced regulatory oversight
• growing quality and traceability obligations
• complex safety governance challenges

Atessia Vigilances supports pharmaceutical companies in:

• post-marketing pharmacovigilance
• French MAH activities
• EU-QPPV and Local Pharmacovigilance Responsible Person (LPPV/RPV) functions
• PSUR/PBRER and RMP activities
• PV Quality Management Systems
• inspection and audit readiness
• safety data management and EudraVigilance compliance

Expertise designed to sustainably secure your regulatory activities across France and Europe.

Efficiently Structure Your Pharmacovigilance Activities


Biotech companies operate in rapidly evolving environments requiring:

• agile organizations
• specialized expertise
• rapid compliance implementation
• progressive structuring of PV systems

Atessia Vigilances supports biotech companies with:

• creation of pharmacovigilance systems
• structuring of safety activities
• clinical and pre-marketing phases
• transition toward post-marketing activities
• targeted regulatory expertise support

Flexible solutions designed to support your growth and secure your development projects.

Meet Local Regulatory Requirements and Secure Your French Operations


MAHs must ensure compliance with local obligations while maintaining efficient coordination with global partners.


Our teams support MAHs with:

• French regulatory obligations
• Local PV Responsible Person activities
• medical information
• local pharmacovigilance operations
• interactions with ANSM
• oversight of partners and distributors
• documentation management and inspection readiness

Strong expertise in French regulatory requirements designed to secure your local pharmacovigilance activities.

Secure the Vigilance Activities of Your Clinical Trials


Clinical trial safety activities require robust organization and continuous monitoring of safety data.


Atessia Vigilances supports CROs and sponsors with:

• SAE and SUSAR management
• DSURs and regulatory reporting
• interactions with investigators and health authorities
• clinical trial safety processes
• quality and compliance activities

Clinical trial vigilance aligned with international requirements and designed to secure Phase II to IV studies.

Strengthen MDR Compliance and Post-Market Surveillance


The European Medical Device Regulation (MDR) requires manufacturers to maintain enhanced surveillance of medical device safety and performance.


Our experts support manufacturers and operators with:

• medical device vigilance
• incident and FSCA management
• PMS and PMCF activities
• MDR obligations
• regulatory audits and inspections
• quality complaint management

Dedicated expertise supporting medical device safety and regulatory compliance across France and Europe.

Secure Your Cosmetovigilance Activities and Consumer Safety


Regulatory requirements applicable to cosmetic products require effective monitoring of undesirable effects and safety data.


Atessia Vigilances supports cosmetic industry stakeholders with:

• undesirable effect management
• cosmetovigilance activities
• regulatory reporting
• post-marketing surveillance
• quality and compliance audits
• product safety investigations

Health vigilance expertise designed to protect consumers and strengthen cosmetic product compliance.

Strengthen the Safety of Your Nutritional Products


Organizations operating in the nutrition sector face increasing requirements regarding health safety and post-marketing surveillance.


Our teams support:

• nutrivigilance activities
• management of undesirable effects
• product risk assessments
• regulatory monitoring
• quality complaint management
• traceability of vigilance activities

A structured approach designed to secure nutritional products and strengthen regulatory compliance.

Structure Your Regulatory Activities from Early Development Stages


Start-ups and innovative healthcare companies must rapidly structure their regulatory activities in order to anticipate:

• clinical development phases
• post-marketing obligations
• investor expectations
• future audits and inspections

Atessia Vigilances supports innovative organizations with:

• implementation of vigilance systems
• compliance strategies
• quality process development
• growth and internationalization projects

An agile support model designed to sustainably support your development.

Efficiently Coordinate Global and Local Activities


International organizations must ensure consistency between:

• global governance
• local regulatory requirements
• outsourced partners
• quality systems
• regulatory oversight activities

Atessia Vigilances supports international organizations with:

• coordination of European and French activities
• global/local operating models
• Local PV activities
• French MAH obligations
• documentation governance and quality oversight

Expertise designed to secure international organizations and strengthen multi-country regulatory compliance.

Flexible and Scalable Solutions


Each organization has:

• its own regulatory maturity level
• specific internal resources
• operational priorities
• regulatory constraints

Atessia Vigilances provides tailored support models including:

• full outsourcing
• targeted support
• operational reinforcement
• strategic consulting
• remediation and transformation of PV systems

An agile organization designed to sustainably address your regulatory and operational challenges.