Samarind - leading the way in eCTD
Samarind's Software Director, Miranda Pothiawala, recently presented on the technical aspects of implementing eCTD (electronic common technical document) at the TOPRA North discussion forum held near Warrington in July. TOPRA is the organisation for professionals in regulatory affairs, of which Miranda is a member.
TOPRA is keen to address the many challenges faced by its members and eCTD is currently the most talked about topic in the world of pharmaceutical regulatory affairs. The discussion forum was designed to 'take the mystery out of eCTD' and with Miranda and TOPRA colleague Peter James from Dao-eRA Ltd sharing their depth of experience in regulatory document management systems, the event was a great success.
Regulatory authorities in the majority of EU member states have a 'strong preference' for receiving pharmaceutical licence applications in eCTD format, which creates a daunting challenge for most regulatory departments; many of whom do not have the necessary tools for submitting their dossiers in eCTD format.
Samarind's long history of developing fit-for-purpose business software includes many years experience of working in the pharmaceutical industry. Miranda has been the architect of numerous software applications covering document management and regulatory submissions including Samarind's own purpose developed regulatory software management application - Samarind RMS.
Samarind RMS is a time-efficient toolset that helps manage and track pharmaceutical licence submissions, document management and of course the system includes the necessary eCTD tools for creating XML based dossiers.
For further information on Samarind RMS please visit www.samarindrms.co.uk or contact Phil Turner by telephone on +44 (0) 1244 288281.
Date added: 18/07/2008
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