DRA Consulting Oy | Pakkalankuja 7 | FI-01510 Vantaa | +358 9 825 64 200 | info@dra.fi | www.dra.fi

It’s not magic, it’s expertise

We are happy to give

you further information.

Contact us:

Hanna Saari

Tel. +358 9 825 64 269

hanna.saari@dra.fi

Examples of our electronic submission services:

eRegulatory IntelligenceMake 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.