about
Atessia Vigilances

About
Atessia
Vigilances

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.
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Expertise Built on Proven Experience
Atessia Vigilances builds upon the historical expertise developed by AnticipSanté, a recognized player in pharmacovigilance and healthcare product safety.

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.
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A Solution-Oriented Approach
Atessia Vigilances acts as both an operational and strategic partner, supporting Life Sciences companies throughout every stage of their regulatory vigilance projects.

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.
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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 ?

Experienced consultants from pharmaceutical companies, CROs, and highly regulated environments.

Compliance with EMA, ANSM, and Good Pharmacovigilance Practices (GVP).

Processes and deliverables designed to support audits and health authority inspections effectively.

  • Full outsourcing or targeted support
  • Operational reinforcement or strategic consulting
  • Seamless integration with your internal teams and partners

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
Strategic Consulting and Support for Pharmaceutical and Life Sciences Organizations

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.
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Amarylys
Expert Resource Outsourcing for Life Sciences Companies

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.
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Atessia Vigilances
Expertise Dedicated to Regulatory Vigilance and Product Safety

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.
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Strategic consulting and comprehensive support

Specialist in outsourcing solutions dedicated to the healthcare industry

Expertise in regulatory affairs and product development

Our expertise
Our Values in Practice
Reliability
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.
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What You Gain by Working with Us
- Reduced regulatory risk

- 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
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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.