We specialize in the management of Individual Case Safety Reports (ICSRs) across all case types, including Spontaneous cases, E2B cases, cases originating from Clinical Studies, Solicited Programs, Market Research Studies, Social Media, Health Authority as well as Literature cases.

Our Case Processing expertise spans from-

• Case intake, Triage, Bookin, Data entry, Quality control, Submission, Follow-up management

• Independent Case quality review

• SAE Reconciliation in Clinical Trials along with Business partner and Call center reconciliation for the Post marketed products

• Management of Safety Data/Legacy Data (Migration activities)

With a deep understanding of case processing activities, we ensure meticulous and accurate handling of safety information.

​

We support Regulatory submissions worldwide, focusing on ensuring regulatory compliance worldwide. We understand the dire need to ensure regulatory compliance to bring the medicinal product from laboratory to life. We dedicate ourselves in maintaining overall project timelines, complying with project specific Key Performance Indicators (KPIs), and Regulatory Compliance to guarantee successful outcomes.

We specialize in mentoring safety personnel to confidently process ICSRs.  We have an experience of training over 50 scientists globally in various aspects of Pharmacovigilance. We prioritize monitoring quality and regulatory compliance to maintain the highest standards. We provide academic training in Clinical Research & Pharmacovigilance to ensure drug safety and regulatory adherence throughout a product’s lifecycle – from pre-market clinical testing to post-market surveillance.

​We have expertise in collaborating with Local QPPVs throughout the world to ensure the successful execution of various activities on behalf of Marketing Authorization Holders (MAH). We also provide support in the creation, maintenance and regular updates of the Pharmacovigilance System Master File (PSMF).

We specialize in the development, negotiation, and maintenance of Safety Data Exchange Agreements (SDEAs) that ensure regulatory compliance and robust pharmacovigilance partnerships. We support both MAHs and partners by defining clear roles, responsibilities, timelines, and data flow processes for case management, aggregate reporting, and signal detection. Our proactive approach reduces compliance risks and strengthens collaboration across global PV networks.

We perform Global and Local Literature Review activities including comprehensive review of published literature articles and abstracts, safety signal detection and analysis. Monitoring and evaluation of product's risk benefit profile along with recommendations for risk minimization or labeling updates.

​

We support preparation of Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs) and Addendum to Clinical Overview (ACO).

We support Risk Management Plan (RMP) creation and updates, Risk Minimization Measures (RMMs): routine and additional, create educational materials,  and evaluate effectiveness of RMMs.

We perform Signal detection activities (qualitative and quantitative) including Signal validation, prioritization, assessment, and confirmation, Signal communication and tracking. We interact with Pharmacovigilance Risk Assessment Committee (PRAC) when applicable.

We perform medical review of safety data impacting labeling, preparation or update of Company Core Safety Information (CCSI) and Company Core Data Sheet (CCDS), review of national product labels and Summary of Product (SmPC).

We provide independent auditing of pharmacovigilance systems, vendors, and affiliates to ensure compliance with GVP, ICH, and local regulatory requirements. Our services cover audit planning, conduct audits, CAPA management, and inspection readiness. Each audit is tailored as per the client’s operationonal needs, ensuring a pragmatic and risk-based approach to compliance oversight.

We offer expert evaluation of existing or developing PV systems to assess current and future needs. Our approach includes mapping and designing compliant, fit-for-purpose safety infrastructures, developing clear procedural documentation, and supporting system implementation. We specialize in building customized PV systems that evolve with company growth and have successfully supported clients through Regulatory Authority such as EMA, MHRA, HPRA, FDA, and Health Canada inspections.