Scientific advice in Europe – where to go?

Both national and central scientific advice are important mechanisms to gain feedback from competent authorities during drug development.

Your choice of adviser is highly dependent on your type of product, the stage of development, your budget and how much time you have at disposal. Today we are sharing a shortlist that might be helpful when planning for EU scientific advice:


National advice from Swedish MPA

– Characterized by openness and dialogue.

– Face-to-face/online meeting or written advice

– Meeting minutes are written by the applicant and reviewed but not formally approved by the MPA. 

– Non-binding

– National view

– Quicker (2-4 months)

– Low cost (~€ 6000)


Central advice from EMA (CHMP)

– More bureaucratic procedure

– Preparatory meeting encouragedFormal written advice (issued by the CHMP)

– Non-binding

– Pan-European view

– Slower (4–6 months)

– Expensive (€51,800 to €103,800) but 90% fee reduction for SMEs

Would you like to know more? Contact us at

”This medicine is great!”

Why can’t I just say that?

Pharmaceuticals aren´t chocolate and when it comes to its promotion, ethics is key.
The pharma industry has a set of ethical rules, complementing the national legislation on marketing. The rules cover a range of areas such as promotional materials, interaction with health care professionals, patient organisation collaboration, transfer of value and more.

At RegFile we support our clients with promotional reviews and guidance for the Nordics, making sure you promote your great product in a balanced and accurate way.

Feel free to reach out:

Orphan drug designation

To achieve orphan designation, it takes more than just proving your drug is intended to treat a rare disease. Besides prevalence data, in EU you will need to show potential for a significant benefit compared to any existing treatments including non-pharmacological methods such as surgery. So US ODD may be the first step.

Together with our strategic experts within the RegSmart team we will support you with your application for ODD in EU as well as in US. We write, guide, coordinate, and submit, making sure all the regulatory requirements are met.

Interested in ODD? – contact

Need help with your Investigator’s Brochure?

Do you have all your data but no one to put it in writing in time for submission? A medical writer may be just what you need! Give us call.


#regfile #medicalwriting #investigatorsbrochure #ib

eCTD publishing

CTD (Common Technical Document) describes the organisation of the regulatory documents supporting the authorisation of medicinal products.



The eCTD (electronic CTD) is a harmonised technical solution to implementing the CTD electronically. It consists of PDF documents, arranged in a set structure with defined folder and document names. eCTD is to be used when submitting documentation to authorities.

eCTD requires a dedicated software that creates separate Table of Contents with hyperlinks to the included documents, XML backbones and hyperlinks between documents.


Need help with eCTD publishing? Give us a call.

Meet the family

Did you know that RegFile is part of the brilliant consultancy group Center for Translational Research?

Last week the CTR siblings met in Sigtuna, to discuss how to develop our complementary services and collaboration to support our clients even better. Current business trends were also on the agenda to make sure we stay on top of things!

CTR consists of RegSmart, Clinical Trial Consultants (CTC), Toxicology Knowledge Team (TKT), MetaSafe, Lablytica and RegFile.

RegFile AB
Eklundshovsvägen 1G, 752 37 Uppsala, Sweden

Proud member of the CTR group