From 13 June, 2016 onwards
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March 7, 2016 Publishing & Submissions -
March 2, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesEnabling Multi-region submissions, effortlessly
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February 9, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesDecode the Health Canada, and US FDA new DMF Submission Mandates
Are you a DMF holder willing to submit your paper Drug Master Files (DMFs) to Health Canada? Or are you looking for a paper DMF submission partner?
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November 4, 2015 Medical Devices, Publishing & SubmissionsSubmissions scheduled for Sep 24, 2016.
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October 17, 2015 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesFDA published a guidance in May 2015 announcing a deadline for electronic submission of active DMFs. As per these guidelines, DMF holders are required to submit the baseline submission that generally includes the Module 1, 2 and 3 of the present submissions. This submission should also take account of the most recent paper submissions if any.
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September 30, 2015 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesIn the last two decades, Thailand, a country with a population of approx. 67 million has witnessed a commendable growth in healthcare sector. After Indonesia, Thailand has the largest drug market that is expected to get double by the year 2020. As per research reports, the Thai government spends 14% on healthcare, which is more than many European countries.
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September 21, 2015 Publishing & SubmissionsThe pharma industry operates in a dynamic and ever changing global environment governed by new regulations and mandates introduced by the Health Authorities. To get compliant with these mandates, companies are required to submit relevant information about their products to health authorities.
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Ever since the eCTD submission became mandatory by FDA in 2008, the life sciences industry has been facing certain difficulties in regulatory processes. Even though the electronic common technical document has been of great help in managing huge volumes of important documentation; there are a few glitches that complicate the submission process for the organizations.
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April 2, 2015 Consumer Healthcare, Medical Devices, Pharmaceutical, Publishing & SubmissionsToday regulatory terms like eCTD, ASPPs, CANDA, SPL, MAA and NDA to name a few are the buzz words in the world of regulatory compliance. While each terminology indicates the inception of the cutting edge technology; they also come with some downright challenges for the life sciences companies.
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December 11, 2014 Publishing & Submissions, Health Authority UpdatesBack in 2012 an ordinance was passed under which all the drug applications to the Saudi Food and Drug Administration (SFDA) were required to be processed through the electronic common technical document (eCTD). It was only till Jan.