Class [42]
Computer & Software Services & Scientific Services
Services for assessing the efficiency of pharmaceuticals including Risk Management Plans (eg RiskMaps: Risk Management Action Plans in drug safety, REMS: Risk Evaluation and Mitigation Strategy in Pharmacovigilance, EU-RMP: European Union Risk Management Plans in Pharmacovigilance, PIPs: Paediatric Investigational Plan), medical assessment and analysis for PSUR: Periodic Safety Update Reports for post marketing activities of a drug, PADER, ASR: Annual Safety Reports, DSUR: Development Safety Update Reports in drug safety, Clinical Safety Reports; Pharmaceutical product evaluation including Signal Detection, Safety Evaluation and Issue Work-Ups arising from signal detection, responding to queries from regulatory authorities on Assessment Reports, PSUR, PADER, ASR, DSUR, SBR Summary Bridging Reports preparation and review, Post Marketing Surveillance (PMS), Preparation of CCDS (Company Core Data Sheet) for the production of labels for each drug, and SmPc for labelling, preparation and development of Clinical Protocol Safety section, Analysis and Review of safety data arising from all phases of clinical trials, assessment and evaluation of individual case safety reports (ICSRs) and processing of Adverse Events (AEs) and ICSRs from clinical trials and post marketing medicines.
Class [44]
Medical, Beauty & Agricultural Services
Pharmaceutical advisory services including mock pharmacovigilance inspections and inspection readiness for audit preparation, Gap Analysis, identifying and prioritizing improvements and CAPA support and Site Audit and strategic planning and advisory services including due diligence activities; Collection of information relating to the use of pharmaceuticals including Safety Data from clinical trials and post marketing surveillance; medical and pharmaceutical consultation including epidemiological literature searches and reviews, AE reporting, conduct of Post Approval Safety Studies (PASS studies), Compassionate Use Program/Expanded Uses programs, report writing and publication, data analysis and data collection.
