A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorisation.

The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacovigilance tool. Numerous steps are involved in the PSUR process including: intake of adverse drug reaction information, case processing, data retrieval, data analysis, and medical review and risk assessment. These processes are heavily reliant on the availability of adequate resources. An overarching principle throughout the PSUR process is the need for a proactive approach in order to identify the critical steps in the process and to have a clear understanding of the consequences of any critical 'mis-step'. With this information comes appropriate planning, building quality into each step of the PSUR process and monitoring performance will maximise the likelihood of generating a quality report. Any failure of a key PSUR process will have the opposite effect - a poor quality report that will give little insight into emerging safety signals or provide misleading information that can adversely affect public health.

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Many Small scale Manufacturers are confused with Dossier compilation and dossier writting,writting dossier is a technical skill and it involves study and review of technical documents of Client and compilation is just a document formating skill which can be handled by any non techincal person.CPPL assures complete compliance of regulatory norms with its strong technical staff and knowledge gained throughout their industrial experiance

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation

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