Chris Englerth

Recent Posts

Drug Master File – Count Down

March, 2017

The FDA deadline on NDA, ANDA, BLA and DMF (paper submissions) is less than 4 weeks away. By 5th of May 2017 the FDA ...

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FDA Update on Electronic submissions from September, 2016

October, 2016

In September 2016, the FDA published new deadlines on electronic submissions: May 5, 2017: NDA, BLA, ANDA and DMFs must ...

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SPOR – Key Activities For The Industry (EMA-Update)

August, 2016

On August 4, 2016, The European Medicines Agency (EMA) hosted a webinar for the industry to further the understanding ...

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How to achieve IDMP compliance

June, 2016

…is a frequently asked question in the regulatory industry. The legislative EU deadline, 1st of July 2016, has kicked ...

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Electronic Application Forms (eAF) update

March, 2016

Since January 1st 2016, all Submissions to the European Union have to include electronic application forms instead of ...

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European eCTD Module 1 Version 3.0 Finalized

November, 2015

EMA eCTD specifications – General Update In October, EMA has officially released the version 3.0 of the European Module ...

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Regulatory Master Data Management – Compliance, Technology and Science

October, 2015

Digital transformation is a hot topic. When applied to health products development, being able to combine science and ...

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