News/Events
Wednesday 02 March 2011 White paper: What’s new with the eCTD submission ?
Since 2010, the eCTD (electronic Common Technical Document) has become the only electronic format accepted by the EMA and recently by national Authorities.
With new regulations on variations, eCTD will be certainly the only electronic format for submission procedures. This allows the pharmaceutical industry to benefit from large advantages such as costs reductions, time-to-market acceleration, streamlining the management of large volume of data and documentation, and mitigating risks of non-compliance.
Many regions around the world have already updated requirements in electronic submission such as Finland, Poland, USA, and Switzerland.
Actually, since January 1st 2011, Swissmedic, the Swiss Agency for Therapeutic Products, has published new guidelines for submissions in eCTD format such as : Questions from industry on electronic-only submission with eCTD, guidance for practical aspects related to eCTD submission to Swissmedic, requirements of a Swiss module 1 in eCTD Format and criteria for technical validation of eCTD submission to Swissmedic (for further information about these guidelines, please consult www.swissmedic.ch).
Expertise in e-submission procedures is an essential aspect in the pharmaceutical product lifecycle. That’s the reason why ProductLife AG with its team of specialists offers consultancy and operational regulatory services for the production of your submissions in all formats (eCTD, NeeS and Paper), in accordance with the latest regulations.
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