Sponsors Gear Up For a Smoother Process With CTIS but Must First Overcome Key Hurdles

June, 2022

Read the latest blog from our Pharmalex colleagues, Milena Shuytsova-Mircheva and Lisa Pascoe, who discuss the benefit ...

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US FDA Provides Reminders for Upcoming eCTD Validation Changes

March, 2022

The DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum, held online and in person from ...

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What Is the EMA DADI Project - and Why Is It Critical to IDMP, eCTD, RIM, and More?

December, 2021

If you are at all familiar with ISO IDMP (Identification of Medicinal Products), you are likely aware that this complex ...

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AI Advances in Life Sciences Regulatory: 2020 Review and 2021 Expectations

December, 2020

Artificial Intelligence (AI) continues to make strides in the life sciences regulatory arena, but many obstacles ...

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AI Powered Automation Proven in Life Sciences

April, 2020

Adapted from a March 25, 2020 Phlexglobal webinar, “How Automation is Transforming Regulatory Compliance in Life ...

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Prepare yourself for 2020 – Global regulatory update

December, 2019

With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

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Common Promotional Submissions in eCTD Errors and How to Avoid Them

November, 2019

Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP ...

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