Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
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July 20, 2016 Pharmaceutical, Publishing & Submissions, Health Authority Updates -
Identify the best suited software ahead of time
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Japan has a unique set of processes and agencies for the regulation of drugs. The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are the two main Regulatory Agencies that oversee the approvals of the drugs as per the regulatory prerequisites in Japan.
Investigational New Drug (IND) Filing Process
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April 5, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesAre 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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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.