NEWS & POSTS

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 info@regfile.se

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.

Happy Easter

Clinical overview – eCTD module 2.5

The Clinical Overview is one of the most important documents on your way to Marketing Authorisation. It is an in-depth critical analysis of your complete drug development programme and its results, including discussion and interpretation of clinical findings.

The overview presents the strengths and limitations of your programme and study results and analyse clinical benefits and risks. It describes how study results support the critical parts of the prescribing information, such as indication, dosage, safety profile and more.

A clinical overview is needed also for generic- and hybrid applications but in these cases the key messages could generally be based on the reference product.
 
Need help writing a clinical overview? Give us a call.

RegFile AB
Eklundshovsvägen 1G, 

752 37 Uppsala, Sweden 

info@regfile.se

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