NEWS & POSTS

PIP submission via IRIS

Are you working on a PIP? 

Please note that paediatric submissions must be submitted via the IRIS platform from 4 June 2024.

 

The following submission types are affected:

• Initial paediatric investigation plan (PIP)

• Modification of PIP

• Product-specific waiver

• Compliance check

• Annual report 

• Confirmation on class waiver, or inclusion of an indication 

• Discontinuation of paediatric development.

 

Not familiar with IRIS? We are. Please  reach out at info@regfile.se

PIP submissions via IRIS

Buying a generic dossier?

Buying a complete drug product dossier at an attractive price may be very tempting!

But what are the chances the file is complete and will be pass a marketing authorisation application in Europe?

Let us help. We regularly perform dossier gap analyses against the EU regulatory framework.

Buying a generic dossier

CTR Easter egg

We got an extra sweet Easter egg this year, filled with our brilliant and sweet siblings at the Center for Translational Research Sweden. We wish all our clients and contacts a sweet and happy Easter too 😊


RegFile

RegSmart Life Science 

QAlliance 

Toxicology Knowledge Team Sweden AB 

MetaSafe 

Lablytica Life Science AB 

CTC Clinical Trial Consultants AB 

CTC Netherlands RegFile AB

Is Europe next?

Are you a small life science company and curious about Europe?

Then it might be time to get in contact with the European pharma agencies. The first step is to find out whether you qualify as a Small Medium Enterprise (SME). As an SME in Europe, you will benefit from several support programs and get significantly reduced agency fees. This is very helpful when moving forward with regulatory activities as for example Scientific advice.

RegFile are happy to support with
• SME evaluation and application
• PRIME
• Central or national scientific advice
• Orphan drug designation request
and more….

Regulatory Europe SME

Promoting your medicinal product

Do you need guidance when promoting your medicinal product or interacting with healthcare professionals?

Do you need a pair of extra eyes to ensure high ethical standard and to navigate regulations and industry standards?

We help you ensuring compliance with the ”Ethical rules for the pharmaceutical industry” as set by LIF (Swedish Association of the Pharmaceutical Industry).

Contact us: info@regfile.se

Promoting your medicinal product

Fast-tracking generic submissions

Are you in need of a combined generic drug bioequivalence testing and submission service?

In the fast-paced world of registering generic products, time is of the essence for running the bioequivalence (BE) study, performing the bioanalysis, and writing the marketing authorisation application dossier (eCTD). 

Our specialized clinical trial unit, provided by Clinical Trial Consultants AB, combined with automated, high-throughput bioanalysis carried out by Lablytica Life Science AB, and synchronized dossier writing and submission services from RegFile AB are designed to meet your needs with quality, speed, and precision.

Get in touch to learn how we can help shorten your project timelines and achieve your goals faster!

👉 rfp@ctc-ab.se

👉 David.Pekar@Lablytica.com

👉 Info@RegFile.se

 

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