Case Management

Case Management

Case Management

Case Management & Regulatory Reporting

Ensure Compliance and Reliability of Your Safety Data

Ensure Compliance and Reliability of Your Safety Data

Pharmacovigilance case management and regulatory reporting are critical activities for Marketing Authorization Holders (MAHs), pharmaceutical companies, and Life Sciences organizations.

Within a regulatory environment governed by European pharmacovigilance requirements (GVP), health authority expectations (EMA, ANSM), and EudraVigilance obligations, the quality of safety data and compliance with regulatory timelines are essential to secure medicinal products and maintain marketing authorization compliance.

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the operational and regulatory management of their pharmacovigilance activities across France and Europe.

Our objective: to ensure reliable, compliant, and inspection-ready management of your safety data and regulatory obligations.

Secure the Processing and Traceability of Your Cases

Management of Individual Case Safety Reports (ICSRs) requires rigorous organization to ensure data quality, regulatory compliance, and timely reporting.

Atessia Vigilances provides:

  • intake and triage of pharmacovigilance cases
  • validation of case reportability criteria
  • MedDRA coding
  • medical and regulatory assessment
  • follow-up management for additional information
  • case quality control
  • management of regulatory reporting timelines


Robust processes designed to ensure reliability, consistency, and compliance of safety data.
Pharmacovigilance Case Management (ICSRs)

Management of Individual Case Safety Reports (ICSRs) requires rigorous organization to ensure data quality, regulatory compliance, and timely reporting.

Atessia Vigilances provides:

– intake and triage of pharmacovigilance cases
– validation of case reportability criteria
– MedDRA coding
– medical and regulatory assessment
– follow-up management for additional information
– case quality control
– management of regulatory reporting timelines

Robust processes designed to ensure reliability, consistency, and compliance of safety data.
An Organization Aligned with European Requirements

Our teams manage pharmacovigilance cases within PV databases and support regulatory submissions to EudraVigilance.

Our services include:

  • data entry and management of ICSRs in PV databases
  • quality control and validation of safety data
  • workflow management and regulatory tracking
  • transmission of cases to EudraVigilance
  • support for reconciliation activities
  • management of local French and European activities


Operational expertise ensuring compliance with EMA and ANSM expectations.
Strengthen the Benefit-Risk Monitoring of Your Products

Periodic safety reports play a central role in the continuous evaluation of the benefit-risk profile of medicinal products. Atessia Vigilances supports:

  • preparation of PSURs/PBRERs
  • cumulative analysis of safety data
  • evaluation of safety signals and trends
  • review of benefit-risk profiles
  • coordination of local and global contributors
  • preparation of regulatory submissions


Scientifically robust reports compliant with health authority expectations.

Secure Your Risk Management Strategy

The Risk Management Plan (RMP) is a key component of medicinal product safety surveillance strategies within Europe.

Our experts support:

– drafting and maintenance of RMPs

– identification of important risks

– definition of risk minimization measures

– integration of pharmacovigilance data

– alignment with EMA requirements

A structured approach designed to strengthen control of product-related risks.

Strengthen the Compliance of Your Regulatory Submissions


The quality of safety data directly impacts the compliance of marketing authorization dossiers and interactions with health authorities.


Atessia Vigilances supports clients with:


– securing pharmacovigilance data

– ensuring regulatory compliance of submissions

– integration of PV requirements into regulatory filings

– preparation for pharmacovigilance inspections

– management of health authority requests



Regulatory expertise designed to sustainably secure your activities and marketing authorizations.

Processes Designed to Support Audits and Inspections


Our activities are integrated within a robust quality system compliant with Good Pharmacovigilance Practices (GVP).


We ensure:


– documented and auditable procedures

– full traceability of activities

– appropriate quality controls

– compliance with regulatory timelines

– organization aligned with EMA and ANSM expectations



Reliable processes designed to reduce regulatory risk and support inspection preparedness.

Why Choose Atessia Vigilances?

Experienced consultants specialized in case management, regulatory reporting, and PV compliance.

Compliance with EMA, ANSM, GVP, and EudraVigilance expectations.

Case management, regulatory reporting, and PV governance coordinated within the same organization.

Full outsourcing, targeted support, or strategic consulting according to your operational requirements.

Processes designed to ensure consistency, traceability, and patient safety.

What You Gain by Working with Us

– Secured regulatory obligations
– Reliable and high-quality safety data
– Compliance with regulatory timelines
– Reduced risk of non-compliance
– Enhanced preparedness for EMA and ANSM inspections

Looking for a Partner in Case Management & Regulatory Reporting?

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the management of pharmacovigilance activities and the security of regulatory obligations across France and Europe.

Contact us