Consolidation!

2025-03-10

RegFile and our neighbour and sister company RegSmart will consolidate!

We cooperate with most projects and have realised that the best way forward is us working as one unit. The RegFile team look very much forward to this arrangement, and we hope you find it beneficial too.

We will operate under RegSmart’s name moving forward. Please check out RegSmart’s website (although not updated with the RegFile team and services yet) to explore the great team and the available services: RegSmart.se

Struggling with eCTD?

2025-01-21

Quality variations

2024-11-19

Let us share some great regulatory tips from Läkemedelsverket (Swedish Medical Products Agency). They have published a list of well-thought-out tips directly from their quality assessors directed to pharma companies. The list details how to compile your quality (CMC) related variation applications in the best way. Take a look:
@https://lnkd.in/denRJuGa

Pharmacovigilance – let us help

2024-11-05

Do you need pharmacovigilance support?

We provide a full pharmacovigilance setup and QPPV to comply with the pharmacovigilance legislation.
We also act as local PV function in the Nordics.
And more.

Will we meet at Nordic Life Science days?

2024-09-02

The RegFile team is back to work and ready for a fresh start! Something we are really looking forward to is the NLS days taking place 18-19 September in Malmö. We will share exhibition booth with our CTR siblings where you are most welcome to visit. There is still time to sign up for NLS if you haven’t already.

See you there! At booth C09

On top of the upcoming guidelines

2024-08-16

The regulatory “bible” for approved products is changing. Obviously, we are talking about the “EC guidelines on variations categories and procedures”. Be prepared and check out the proposal for stakeholder consultation: european-commission-guidelines-variations-categories-procedures-proposal-stakeholder-consultation-track-changes_en.pdf (europa.eu)

There are many changes in this version, relating to IA super grouping, work-sharing, flexibility for vaccines, addition of API suppliers and more. Read the Executive summary for a complete overview:
executive-summary-proposed-amendments-european-commission-guidelines-variations-categories-procedures_en.pdf (europa.eu)

We will follow the updates closely and make sure to keep you updated.

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