Publishing & Submissions

IND and NDA Regulatory Submissions in Japan- Decoded

May 3, 2016 Regulatory Affairs, Publishing & Submissions, Health Authority Updates

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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eCTD Module 1 V3.0 for EU – What should companies know about the revised specification?

April 5, 2016 Pharmaceutical, Publishing & Submissions, Health Authority Updates

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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UAE to implement the eCTD for Streamlined Pharmaceutical Products’ Registration

March 31, 2016 Pharmaceutical, Publishing & Submissions, Health Authority Updates

With 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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PSUR Submissions to be directed towards central repository at EMA

March 7, 2016 Publishing & Submissions

From 13 June, 2016 onwards

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Electronic submissions: A boon or bane?

March 2, 2016 Pharmaceutical, Publishing & Submissions, Health Authority Updates

Enabling Multi-region submissions, effortlessly

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Why should Companies give up Paper DMF Submissions?

February 9, 2016 Pharmaceutical, Publishing & Submissions, Health Authority Updates

Decode 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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Heads-up: Class II Device’s UDI Compliance is here

November 4, 2015 Medical Devices, Publishing & Submissions

Submissions scheduled for Sep 24, 2016.

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DMF Submission to go Electronic

October 17, 2015 Pharmaceutical, Publishing & Submissions, Health Authority Updates

FDA 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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Thailand Moving Forward to eCTD Submissions

September 30, 2015 Pharmaceutical, Publishing & Submissions, Health Authority Updates

In 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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Global Markets Shifting Towards eCTD

September 21, 2015 Publishing & Submissions

The 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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