Are you currently submitting eCTDs (electronic common technical documents) to European Region (EU)? Or planning for the same in near future? Then we suggest it’s time to pull up your socks as the EU is taking its turn in 2016.
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April 5, 2016 Pharmaceutical, Publishing & Submissions, Health Authority Updates -
March 31, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesWith an announcement made on 3rd March, 2016 by the UAE Ministry of Health & Prevention, UAE becomes the second nation to implement eCTD in the MNEA region. All the pharmaceutical and health service provider companies are asked to follow eCTD structure and format of submission for new registrations of medicines.
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March 7, 2016 Publishing & SubmissionsFrom 13 June, 2016 onwards
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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.