Safety & Pharmacovigilance
Our expert teams ensure safety from clinical development to post-marketing, combining global expertise with local insight. We deliver end-to end vigilance solutions to support compliance and patient protection.
With exploding data volumes and zero room for regulatory error, the global safety market demands absolute scalability
In an increasingly stringent regulatory landscape, ensuring patient safety while maintaining compliance across multiple jurisdictions is a major challenge for life sciences companies. Managing diverse vigilance streams, from pharmacovigilance to device and cosmetic safety, requires seamless operations, real-time data monitoring, and deep regulatory expertise to mitigate risks and protect global health.
Aixial’s achievements & specialties
Experienced team in Pharmacovigilance Cosmetovigilance
From early phase clinical development through to post-marketing
Regulatory compliance & Operational excellence
Protecting patient safety, ensuring regulatory excellence
At Aixial Group, we deliver end-to-end pharmacovigilance solutions designed to ensure patient safety, regulatory compliance, and operational excellence. Our integrated approach combines expert-driven services, advanced technologies, and proven methodologies to support pharmaceutical and biotech companies across the entire safety lifecycle.
Areas in safety & vigilance
Pharmacovigilance
End-to-end case management from clinical phases to post-marketing (ICSR processing).
EU-QPPV / Local QPPV provision and back-up services.
Signal detection, risk management, and benefit-risk profile evaluation.
Materiovigilance
Incident tracking, reporting, and management of Field Safety Corrective Actions (FSCA/FSN).
Post-Market Clinical Follow-up (PMCF) assessment and Periodic Safety Update Reports (PSUR).
Risk analysis and seamless interface with Competent Authorities.
Cosmetovigilance
Collection, evaluation, and reporting of adverse events (AE) and serious adverse events (SAE).
Continuous updates of Cosmetic Product Safety Reports (CPSR).
Global regulatory monitoring and safety counseling for international markets.
Nutritovigilance
Monitoring of adverse effects related to the consumption of food supplements or novel ingredients.
Scientific causality and assessment of imputability.
Official declarations and reporting to national and international food safety agencies (e.g., EFSA, FDA).
What we can deliver
Literature surveillance & signal identification
End-to-end case management (ICSRs)
Periodic safety reports (PSUR, DSUR, PBRER)
Risk Management Plans (RMP)
Signal detection & monitoring
SDEA management
Medical information handling
Inspection & audit support
Our multidisciplinary safety teams
Our experienced professionals bring deep knowledge and operational excellence:
Safety Officers
Safety Physicians / Medical Monitors
Safety Database Experts
Pharmacists
Doctors
Tools & technologies
Powered by industry-leading platforms
We leverage validated systems and global standards to ensure accuracy, compliance, and efficiency:
- Safety Systems: Argus, Safety Easy, Veeva Vault
- Global Dictionaries: MedDRA, WHO Drug
- Databases & Monitoring: EudraVigilance, Embase, PubMed
Measurable outcomes: performance you can trust
We ensure consistent quality and strict regulatory compliance in every deliverable.
Why Aixial Group?
By combining expert talent, robust processes, and cutting-edge technologies, Aixial Group ensures seamless pharmacovigilance operations that enhance safety oversight and drive regulatory success.
Q&A
What pharmacovigilance services does Aixial Group provide?
We offer complete, end-to-end global safety and pharmacovigilance (PV) solutions from early-phase clinical trials to post-marketing surveillance. This includes ICSR case management, aggregate reporting (DSUR, PSUR/PBRER), global medical literature monitoring, signal detection, and Risk Management Plans (RMP).
What operational models do you offer ?
To match your internal infrastructure and budget, we offer flexible delivery models:
Functional Service Provision (FSP): Dedicated professionals integrated into your team, working as an extension of your organization to provide ongoing support and expertise.
Consulting & operational support: Flexible expert services delivered on demand to address specific challenges, support projects, and strengthen your operations.
Which safety databases and technology platforms do you master?
Our teams are experts in the industry’s leading safety databases, including Argus, Safety Easy, and Veeva Vault Safety. We are completely tool-agnostic and ensure our designers are continuously trained on the latest tool releases to adapt to your preferred technology stack.
How does Aixial Group ensure global regulatory compliance?
We strictly align our processes with ICH, EMA, and FDA guidelines, maintaining an industry-leading record of 100% on-time safety reporting. Our safety experts and medical reviewers continuously monitor regulatory updates to guarantee that your clinical trials and commercial products remain fully compliant.
Can you handle safety and vigilance for products outside of pharmaceuticals?
Yes. Our highly skilled consultants provide tailored safety and vigilance solutions across the entire life sciences spectrum, including pharmaceuticals, medical devices (Materiovigilance), cosmetics (Cosmetovigilance), and food & nutrition (Nutrivigilance).
How can we support your next project?
Whether you’re looking for a protocol review or a proposal,
simply reach out to us by filling our request for proposal.
