From 1 January 2021, Northern Ireland will continue to participate in referrals under Article 29. For applications where the MHRA had a positive opinion at Day 210 of a DCP or Day 90 of an MRP, a Marketing Authorisation will be granted following receipt of the national product information. No additional or different fee will be charged for applications that are completed as a national procedure having previously been referred under Article 29.
What our Clients Say?
We have had a good impression of Freyr and feel more than comfortable telling our partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.
Director, Regulatory Affairs,
US based leading precision medicine company
Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. I thought the support was very good and met with expectations. In addition, found the price reasonable given the workload.
Director, Regulatory Affairs,
US based leading precision medicine company
You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!
Regulatory Affairs Officer
A Global Industry Leader in Medical Device Design and Manufacturing
Thank you so much Freyr team for your support on the way in registering 3 of our medical devices in Philippines.
I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.
Associate, Regulatory Affairs Team II,
Clinical & Regulatory Affairs Center,
A Korean Chemical Company
Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. That’s what is really important and gratifying. Thank you again and keep up the excellent work!
Manager, Regulatory Affairs
A Spanish Medical Devices Manufacturer
The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?
Director, Regulatory Affairs
US based top Sterilization company
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