The European Medicines Agency (EMA) has recently published Version 1 of the EU IDMP Implementation Guide that aims to inform stakeholders about the…

In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory as of 30 June 2022.

This blog has been formulated to help guide you on your transition to the cloud and to assist you in finding the ideal cloud provider for your…

In this blog post, we talk about the benefits of the cloud and how they apply to organizations within the life sciences industry.

The Board of the Eurasian Economic Union has published decisions on the electronic submission of drug applications. These include decisions 78 and 79…

The cloud revolution is here, and businesses around the world are enjoying the many benefits that cloud-based computing offers.

On 26 May 2020, the new EU Medical Device Regulation and the EU In-vitro Diagnostics Devices Regulation will come into effect. This blog post will…

In this blog post we highlight the most important changes to be wary of in the case of a no-deal Brexit, according to the UK government.

From 01 January 2020, Health Canada will only accept new DMF applications submitted in eCTD format to enable a common submission intake process as…

The final version of the HMA eSubmission roadmap has been updated on 21 June 2019.

In this article, we go through some of the general technical validation requirements and how to better understand them. 

There are currently many ongoing activities and discussions relating to Brexit and its potential implications across many different sectors.

中国药品监督管理局（CDA）宣布，eCTD将成为中国境内电子提交材料的强制性标准。尚未开始为新的监管要求做准备的生命科学组织收到建议，其需要迅速采取行动，以满足即将来临的最后期限。

The MHRA is introducing baseline submissions to assist the conversion from NeeS to eCTD. In this blog post we talk about what a baseline submission…

As eCTD is becoming mandatory in more and more countries, it is at this point your Regulatory Operations team will need to transform their…

With the FDA eCTD mandate for INDs and DMFs upon us, now all original applications and lifecycle submissions for human drugs and biologics must be…

In this article, we will talk about EMA eSubmission gateway, CESP (Common European Submission Platform) and the future of both platforms; CESSP…

 In below sections I will discuss some portable document format (PDF) specifications that you should also consider while publishing your submissions.

We are upon uncertain times within the Regulatory world. The FDA has already started moving toward making eCTD mandatory for all submissions by May of…

The end of 2018 will mostly mark the end of the practice of submitting dossiers for medicinal products marketed for humans in the two electronic…

On October 4th the FDA released its version of the ICH M4 Granularity guidance, covering its thinking on granularity and keyword usage in eCTD 3.2 and…

In this, the final post the eCTD 4.0 blog post series, we shed light on the expected eCTD 4.0 implementation plans and timelines.

eCTD 4.0 has a variety of different new terminology. To make sure you can tell the difference between your CoU’s and UUID’s, this blog post will walk…

In recent years, a lot has happened surrounding the development and evolution of the eCTD standard. You have probably already sat through an eCTD 4.0…

The European Medicines Agency (EMA) recently released a business continuity plan dealing with the potential implications of Brexit. Currently based in…

As of 2019, the Chinese Food & Drug Administration (CFDA) has announced that eCTD will become mandatory for electronic submissions within China. Life…

On May 22, 2017 the European Medicines Agency’s (EMA) management board endorsed the start of the official countdown for the launch of the improved…

The EMA recently announced that they will be delaying the roll-out of the new ISO IDMP standard within Europe until after the completion of the formal…

From the beginning of next year, Health Canada will only accept submissions for certain regulatory procedures in the electronic common technical…