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It’s not magic, it’s expertise
eRegulatory Intelligence
Make sure your product gets off to a good start. Strategic planning builds a solid foundation for successful
product lifecycle management and ensures that the regulatory process runs smoothly. Our eRegulatory
knowledge and expertise play a key role with the planning of your eRegulatory strategy.
Our specialists are at hand to help you whether you need assistance in publishing your application in
eCTD or NeeS format or for the strategic planning of the eCTD lifecycle management for your product.
We participate early in the planning of your electronic publication, already at the preparation phase of the
documentation, by training the writers to observe the requirements for electronic publications and thus
reduce the maintenance work necessary at later stages of the product’s lifecycle. In addition, we provide
expert assistance in the planning of your company’s eRegulatory strategy.
DRA Consulting Oy is participating in the pilot phase of the Common European Submission Portal (CESP)
and the pharmaceutical industry reference group for Fimea’s Säihke II project.
DRA Consulting Oy holds a certificate for the electronic submission of information of medicines to the
EudraVigilance database. We can assist you in sending the required information to EMA. We can also give
you consultation of the registration and submission phase.
We are here to help you in your electronic submissions.
Examples of our electronic submission services:
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We are happy to give
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you further information.
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Contact us:
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Hanna Saari
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Tel. +358 9 825 64 269
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hanna.saari@dra.fi
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DRA Consulting Oy | Pakkalankuja 7 | FI-01510 Vantaa | +358 9 825 64 200 | info@dra.fi | www.dra.fi