Class [42]
Computer & Software Services & Scientific Services
Services for assessing the efficiency of pharmaceuticals incluiding Risk Management Plans (eg RiskMAps, REMS,EU-RMP,PIPs) , medical assessment and analysis for PSUR, PADER, ASR, DSUR, Clinical Safety Reports; and 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 preparation and review, Post Marketing Surveillance (PMS) , Preparation of CCDS and SmPc for labelling, prepartion 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 advisiory 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 phamaceuticals including Safety Data from clinical trials and post marketing surveillance; and Medical l and pamaceutical consultation including epidemiological literature searches and reviews, AE reporting, conduct of Post Approval Safety Studies (PASS studies), Compassionate Use Program/ Expanded Users programs, report writing and publication, data analysis and data collection.
