NEWS & POSTS

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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IRIS roll-out for life-cycle management

Are you ready for the IRIS roll-out for Product Lifecycle Management Procedures?
 
IRIS will become the new submission management system and communication portal at EMA. The first roll-out is live since 23 January 2024, including submission management of variations, Art.61(3) notifications and MAH transfers for a subset of centrally authorised products.

EMA will no longer use EudraLink as communication portal for these products in the procedural steps covered by IRIS.

Later this year PSURs, PAMs, line extensions, renewals, annual assessments, PASS, and referrals will also be rolled out.
 
Need help? Contact us at info@regfile.se

IRIS roll-out for life cycle management

Let’s finish your UFOs

Any UFOs (=UnFinished Objects) on your desktop? Such as regulatory reports and summaries that you never seem to have time for. Consider our regulatory/medical writing services.

 

info@regfile.se

Let's finish your UFOs

Veterinary product information v.9

Have you updated your veterinary product information to QRD v. 9 yet?

The EU Veterinary Medicinal Products Regulation (2019/6) entered into force on January 28, 2022, replacing the former directive. The regulation introduced a new version of the QRD template, requiring structural updates to the SmPC, package leaflets and labelling. All existing veterinary products will need to transition to the template before 29 January 2027.

There is still some time left, but the general recommendation is not to wait until the last minute.

Do you need help? Contact us at info@regfile.se.

Veterinary product information QRD v.9

Struggling with IRIS?

Are you struggling with IRIS and other regulatory systems?

At RegFile we regularly make scientific and regulatory submissions via IRIS. We can guide and support you through all steps needed for your submission to reach the agency in good shape.

We also offer support with the compilation of background materials, enhanced by subject matter experts and a skilled medical writer.

Struggling with IRIS

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 info@regfile.se.