about
Atessia Vigilances
About
Atessia
Vigilances
Today, pharmacovigilance and healthcare vigilance activities go far beyond operational obligations: they have become strategic pillars of governance, quality, compliance, and health authority inspection preparedness.
Atessia Vigilances supports Life Sciences companies in structuring, supervising, and optimizing their regulatory vigilance activities across France and Europe.
Our mission: to secure your vigilance activities, ensure the quality of your safety data, and maintain sustainable regulatory compliance through inspection readiness.
This long-standing expertise enables us to rely on:
- Strong operational experience in regulated environments
- In-depth knowledge of EMA and ANSM expectations
- Methodologies proven under real-world conditions
- A strong quality and compliance culture
- Hands-on expertise tailored to the challenges faced by Life Sciences companies.
A robust foundation of expertise ensuring continuity, reliability, and regulatory compliance for our clients.
Our teams support: - post-marketing pharmacovigilance activities
- clinical trial safety and pharmacovigilance
- safety case management (ICSRs, SAEs, SUSARs)
- regulatory reporting (PSURs, PBRERs, DSURs, RMPs)
- global literature monitoring and regulatory intelligence
- Signal Management activities
- EudraVigilance compliance
- PV Quality Management Systems
- audit and inspection readiness programs
Practical, compliant, and operational solutions designed to address your regulatory and organizational challenges.
Your Expert Partner in Regulatory Vigilance Across France and Europe
Your Expert Partner in Regulatory Vigilance Across France and Europe
In an increasingly demanding regulatory environment, pharmaceutical companies, biotech firms, Marketing Authorization Holders (MAHs), and Life Sciences organizations must ensure compliance of their vigilance activities while strengthening patient safety and regulatory risk management.
Today, pharmacovigilance and healthcare vigilance activities go far beyond operational obligations: they have become strategic pillars of governance, quality, compliance, and health authority inspection preparedness.
Atessia Vigilances supports Life Sciences companies in structuring, supervising, and optimizing their regulatory vigilance activities across France and Europe.
Our mission: to secure your vigilance activities, ensure the quality of your safety data, and maintain sustainable regulatory compliance through inspection readiness.
Why choose Atessia Vigilances ?
Specialized Expertise in Regulatory Vigilance
Experienced consultants from pharmaceutical companies, CROs, and highly regulated environments.
Strong Knowledge of European and French Regulatory Requirements
Compliance with EMA, ANSM, and Good Pharmacovigilance Practices (GVP).
An Inspection-Ready Approach
Processes and deliverables designed to support audits and health authority inspections effectively.
Agile and Flexible Organization
- Full outsourcing or targeted support
- Operational reinforcement or strategic consulting
- Seamless integration with your internal teams and partners
A Pragmatic and Solution-Driven Mindset
Actionable recommendations tailored to your operational and regulatory challenges.
An ecosystem of expertise serving healthcare industries.
Atessia Vigilances is part of a complementary ecosystem of expertise dedicated to the Life Sciences industry.
Atessia Life Science Advisors supports pharmaceutical companies, biotech firms, and Life Sciences organizations in their structuring, transformation, and regulatory governance challenges.
Key areas of expertise include:
• organization of regulatory, quality, and vigilance activities
• global/local operating models
• organizational transformation and optimization projects
• growth, launch, and international expansion strategies
• governance of regulatory and compliance activities
• operational performance and risk management challenges
This expertise helps healthcare companies:
• evolve their organizations
• secure regulatory activities
• adapt to complex regulatory environments
• establish sustainable and compliant operating models
A strategic and operational vision designed to support Life Sciences organizations in their transformation journey while strengthening regulatory and quality performance.
Amarylys supports pharmaceutical companies and biotech organizations through the provision of highly qualified consultants fully integrated into client teams.
Areas of expertise include:
- regulatory affairs
- quality and compliance
- pharmaceutical operations
- pharmacovigilance
-transformation and development projects
A flexible solution enabling rapid reinforcement of operational capabilities and critical expertise.
Atessia Vigilances supports Life Sciences companies in:
• pharmacovigilance
• specialized healthcare vigilance activities
• French MAH local activities
• PV Quality Systems
• inspection readiness
• French and European regulatory compliance
Operational and regulatory expertise designed to sustainably secure vigilance activities and healthcare product compliance.
Conseil stratégique et accompagnement des organisations pharmaceutiques et Life Sciences
Atessia Life Science Advisors accompagne les laboratoires pharmaceutiques, biotechs et acteurs des sciences de la vie dans leurs enjeux de structuration, de transformation et de gouvernance réglementaire.
Les équipes interviennent notamment sur :
- l’organisation des activités réglementaires, qualité et vigilance
- les modèles opérationnels global / local
- les projets de transformation et d’optimisation des organisations
- les stratégies de croissance, lancement et internationalisation
- la gouvernance des activités réglementaires et compliance
- les enjeux de performance opérationnelle et de maîtrise des risques
Cette expertise permet d’accompagner les industriels de santé dans :
- l’évolution de leurs organisations
- la sécurisation de leurs activités réglementaires
- l’adaptation à des environnements réglementaires complexes
- la structuration de modèles durables et conformes
Une vision stratégique et opérationnelle conçue pour accompagner durablement les transformations des organisations Life Sciences et renforcer leur performance réglementaire et qualité.
Délégation de ressources expertes pour les industriels de santé
Amarylys accompagne les laboratoires pharmaceutiques et biotechs grâce à la mise à disposition de consultants spécialisés intégrés directement aux équipes clients.
Les expertises couvrent notamment :
- les affaires réglementaires
- la qualité et la compliance
- les opérations pharmaceutiques
- la pharmacovigilance
- les projets de transformation et développement
Une solution flexible permettant de renforcer rapidement les capacités opérationnelles et les expertises critiques.
Expertise dédiée à la vigilance réglementaire et à la sécurité des produits
Atessia Vigilances accompagne les industriels de santé sur :
- la pharmacovigilance
- les vigilances sanitaires spécialisées
- les activités exploitant France
- les systèmes qualité PV
- l’inspection readiness
- la conformité réglementaire France & Europe
Une expertise opérationnelle et réglementaire conçue pour sécuriser durablement les activités de vigilance et la conformité des produits de santé.
Strict adherence to regulatory timelines, commitments, and quality standards.
Expertise
Experienced teams operating in highly regulated and inspection-ready environments.
Transparency
Clear communication, full documentation traceability, and controlled governance.
Agility
Adaptability to each client’s operational, regulatory, and organizational constraints.
Values applied concretely throughout every project and partnership.
- Sustainable security of your vigilance activities
- Strengthened pharmacovigilance compliance
- Improved safety data quality
- Optimization of internal resources
- Enhanced preparedness for EMA and ANSM inspections
- Flexible support combined with senior expertise
A culture focused on compliance and partnership
Looking for an Expert Partner in Regulatory Vigilance?
Atessia Vigilances supports pharmaceutical companies, biotech firms, CROs, and Life Sciences organizations in structuring, securing, and maintaining compliant vigilance activities across France and Europe.