Regulatory intelligence

Regulatory Intelligence

Regulatory Intelligence

International and local Literature Monitoring & Regulatory Intelligence

Anticipate Safety Signals and Secure Your Regulatory Compliance

In an evolving regulatory environment, monitoring scientific data and health authority requirements has become a strategic challenge for pharmaceutical companies, biotech firms, Marketing Authorization Holders (MAHs), and healthcare product manufacturers.

International and local literature monitoring and regulatory intelligence play a critical role in:

– early detection of safety signals

– compliance with pharmacovigilance obligations

– continuous monitoring of product benefit-risk profiles

– oversight of international regulatory developments

Atessia Vigilances supports Life Sciences organizations in implementing robust, compliant, and inspection-ready intelligence systems tailored to both local and International and local regulatory obligations.

Our objective: to help you anticipate risks, strengthen safety surveillance, and ensure sustainable compliance of your vigilance activities.

Detect Emerging Signals and Strengthen Decision-Making


European and international health authorities require MAHs and operators to continuously monitor scientific data that may impact the safety profile of healthcare products.


Atessia Vigilances implements a structured intelligence framework enabling:


  • identification of literature-derived cases
  • detection of emerging safety signals
  • monitoring or regulatory developments
  • integration of new data into pharmacovigilance systems
  • support for Signal Management and benefit-risk management activities

 


A proactive surveillance approach designed to strengthen control of scientific and regulatory risks.

Meet Pharmacovigilance Regulatory RequirementsScientific literature monitoring represents a major regulatory obligation within pharmacovigilance activities.

Our teams provide :

  • review of international and local scientific literature
  • structured monitoring of international bibliographic databases, including: PubMed, Embase, local and regional literature sources
  • identification of published ICSRs
  • triage and medical assessment of publications
  • detection of relevant safety information
  • management of literature-derived cases
  • monitoring of literature-related regulatory obligations


A surveillance framework compliant with EMA, GVP, and ANSM requirements, based on robust methodologies and internationally recognized scientific sources.

Secure Your Local Literature Surveillance Obligations


In accordance with Good Pharmacovigilance Practices (GVP), MAHs and operators must monitor local literature to identify pharmacovigilance cases published within relevant countries.


Atessia Vigilances supports clients in implementing Monitoring of Local Literature (MLM) systems compliant with European requirements.


Our experts support:

  • surveillance of local and regional publications
  • identification of ICSRs from local literature
  • medical and regulatory validation of cases
  • quality control of literature-derived data
  • integration of cases into PV databases
  • associated regulatory submissions
  • documentary traceability of MLM activities



A structured and inspection-ready approach designed to ensure compliance of your MLM activities across Europe.

Anticipate Regulatory Developments and Compliance Requirements


Regulatory developments directly impact MAH obligations and pharmacovigilance systems.


Atessia Vigilances continuously monitors:


  • EMA and ANSM publications
  • updates to Good Pharmacovigilance Practices (GVP)
  • new ICH recommendations
  • inspection-related requirements
  • local and European regulatory developments
  • Our experts support clients with:
  • regulatory impact assessments
  • adaptation of internal processes
  • updates of quality documentation
  • reinforcement of regulatory compliance



Regulatory intelligence designed to reduce the risk of non-compliance and strengthen PV governance.

Strengthen Your Pharmacovigilance System


Early detection of safety signals is essential to ensure effective monitoring of product benefit-risk profiles.


Our teams contribute to:


  • identification of trends and emerging safety signals
  • analysis of literature-derived safety data
  • medical review of critical information
  • integration of findings into Signal Management activities
  • support for safety and medical teams



A proactive approach designed to anticipate risks and support safety decision-making.

Ensure Compliance with Regulatory Reporting Obligations


Scientific publications may contain pharmacovigilance cases requiring regulatory reporting.


Atessia Vigilances provides:

  • identification of potential cases
  • validation of case reportability criteria
  • processing of literature-derived ICSRs
  • MedDRA coding
  • integration into PV databases
  • EudraVigilance submissions where applicable



Reliable and traceable processes designed to meet international regulatory requirements.

Robust and Auditable Processes


Our intelligence systems are integrated within a quality framework aligned with health authority expectations.


We ensure:


  • documented and auditable procedures
  • full traceability of activities
  • appropriate quality controls
  • performance monitoring KPIs
  • consistent integration within your International and local PV system



An organization designed to support ANSM and EMA audits and inspections effectively.

Why Choose Atessia Vigilances?

Experienced consultants specialized in literature monitoring, case management, and regulatory surveillance.

Compliance with EMA, ANSM, and GVP expectations.

Scientific intelligence, regulatory surveillance, and pharmacovigilance integrated within the same governance framework.

Processes designed to support health authority audits and inspections.

Full outsourcing or targeted support according to your operational needs.

Surveillance systems designed to anticipate signals and secure safety decision-making.

What You Gain by Working with Us

– Secured regulatory obligations
– Early detection of safety signals
– Reduced risk of non-compliance
– Strengthened pharmacovigilance systems
– Enhanced preparedness for regulatory inspections

Looking for a Partner in International and local Literature Monitoring & Regulatory Intelligence?

Atessia Vigilances supports healthcare organizations in implementing reliable, compliant, and inspection-ready intelligence systems tailored to pharmacovigilance and regulatory surveillance activities.

Contact us