on 11 Jun 2009
Last Applicant/ Owned by
Symogen Limited
26 Newfield Road, Marlow, Buckinghamshire
, , SL7 1JW
Serial Number
UK00002518771 filed on 11th Jun 2009
Registration Number
UK00002518771 registered on
2th Oct 2009
Correspondent Information
Andrew Tzialli
Philip Lee, 7-8 Wilton Terrace
Dublin 2,
DO2 KC57
Education and providing of training.
Scientific and technological services including medical assessment and analysis for Periodic Safety Update Reports (PSUR) for post authorisation activities of a drug, Periodic Adverse Drug Event Reports (PADER), Annual Safety Reports (ASR) of a drug and Development Safety Update Reports (DSUR) in drug safety, Clinical Safety Reports, Signal Detection, Drug Safety Analysis and Evaluation, responding to queries from regulatory authorities on Assessment Reports, Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Event Reports (PADER), Annual Safety Reports (ASR), Development Safety Update Reports (DSUR) , preparation and review of Summary Bridging Reports (SBR), Post Marketing Surveillance of medicines once they are used in the public domain, Preparation of Company Core Data Sheet (CCDS) for the production of labels for a drug and Summary of Product Characteristics (SmPc) for prescriber and patient guidance, 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) from clinical trials and post authorisation medicines.
Medical services including mock pharmacovigilance inspections and inspection readiness for audit preparation, analysis of gaps present in pharmacovigilance systems and processes compared to standard set by medical regulatory authorities, identifying and prioritizing improvements for Pharmacovigilance systems and processes and Corrective And Preventive Action for pharmacovigilance support and Site Audit and strategic planning and advisory services including due diligence for pharmacovigilance activities; and pharmacy advice including epidemiological literature searches and reviews, reporting on an Adverse Event of a drug, conduct of Post Approval Safety Studies of a medicine (PASS studies), Compassionate Use Programs/Expanded Uses programs which use drugs for treatment of patients before regulatory authorisation and report writing and publication, data analysis and data collection of Compassionate Use Programs/Expanded Uses programs.
UK00002518771
Figurative
Individual