Dedicated Qualified Persons for Pharmacovigilance ensuring 24/7 compliance and oversight.

CORONIS provides both EU and Local QPPV and Deputy QPPV services to ensure uninterrupted pharmacovigilance compliance.
Our QPPVs maintain round-the-clock availability and act as the main contact for competent authorities.
They oversee system performance, risk management activities, and compliance with GVP requirements — ensuring your PV system operates effectively and consistently across all territories.

Transparent documentation of your PV system and activities.

We create and maintain your Pharmacovigilance System Master File (PSMF) in line with GVP Module II and EMA expectations.

Our experts ensure that all sections are up to date, accurately reflecting your organizational structure, responsibilities, and system performance.

Regular reviews and audits guarantee that your PSMF remains compliant, inspection-ready, and aligned with evolving regulations.

Defining clear safety exchange responsibilities across partners.

CORONIS drafts, negotiates, and manages Safety Data Exchange Agreements (SDEAs) between marketing authorization holders, CROs, and third parties.

We ensure clear definition of safety reporting responsibilities, timelines, and data-sharing procedures.

Our proactive oversight helps maintain transparency, compliance, and readiness for audits and inspections.

Efficient processing and reporting of individual safety cases.

Our PV team manages Individual Case Safety Reports (ICSRs) from collection through entry, medical review, and reporting to competent authorities.

We ensure data completeness, accurate medical assessment, and compliance with EudraVigilance and national reporting timelines.

All cases are tracked, reconciled, and archived with full audit traceability.

Comprehensive periodic reporting that ensures continuous product safety evaluation.

CORONIS prepares and updates Periodic Safety Update Reports (PSURs)/ Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs), and in full alignment with EMA and ICH guidelines.

Our medical and regulatory teams synthesize clinical and post-marketing data, perform cumulative analyses, and draft risk-benefit evaluations ready for submission.

Reliable handling of quality and safety-related product feedback.

We manage product quality complaints (PQCs) linked to safety or performance, ensuring prompt assessment, investigation, and reporting.

Our team coordinates with Quality Assurance and Regulatory Affairs to ensure appropriate CAPA actions and compliance with GVP and GMP requirements.

Consistency between clinical and safety data throughout the development lifecycle.

CORONIS performs regular safety data reconciliation between clinical and post-marketing sources, verifying that all adverse events are consistently captured, coded, and reported.

This ensures data alignment, reduces audit findings, and enhances the integrity of safety datasets.

Proactive detection and evaluation of emerging safety concerns.

Our PV team implements systematic signal detection and management activities, including data review, signal validation, and trend analysis.

We assess potential safety signals in collaboration with QPPVs and regulatory authorities, ensuring timely communication and risk mitigation.

Ensuring full compliance with EU electronic reporting requirements.

CORONIS provides EudraVigilance registration, setup, and ongoing management for sponsors and MAHs.

We ensure compliance with EVMPD and XEVMPD requirements, submission of ICSRs, and management of system updates in accordance with EMA guidance.

Empowering teams with knowledge and compliance awareness.

Our PV experts deliver customized Pharmacovigilance training programs for sponsor staff, investigators, and affiliates.

Training covers GVP fundamentals, AE/SAE identification and reporting, literature surveillance, and inspection readiness — ensuring competence and regulatory understanding across all stakeholders.

Ongoing review of published data for emerging safety information.

We perform systematic literature surveillance in accordance with GVP Module VI, monitoring indexed journals and databases for safety signals and case reports.

Our team provides monthly summaries, case listings, and evaluations that feed into your safety database and regulatory reports.

Staying ahead of evolving global pharmacovigilance requirements.

CORONIS continuously monitors regulatory developments in pharmacovigilance to provide proactive regulatory intelligence updates.

We track EMA, FDA, and national authority communications, interpret new requirements, and support your organization in updating SOPs, systems, and processes accordingly.

Monitoring and managing safety of cosmetic products.

Our Cosmetovigilance services ensure full compliance with current European safety requirements for cosmetic products.

We collect, assess, and report undesirable effects, manage product notifications, and prepare periodic safety summaries — helping maintain product safety and consumer confidence.

Ensuring safety compliance for medical devices and diagnostics.

CORONIS supports medical device vigilance and post-market surveillance in accordance with MDR and IVDR requirements.

We manage incident reporting, trend analysis, and regulatory communications to ensure ongoing device safety, performance, and compliance with authority expectations.