Client Reviews

Succesful Outcome of an EMA Procedure

Dear Anja:

We really want to thank you the dedication and the great work you have done during the [...] process.

It has beeen a pleasure to work with you and we really have learned a lot seeing how you handled all the meetings and the questions raised.

We would like to count on your support and help in future projects.

As promised, please recieve and take the best care of these three bottles of red wine. It is one of the best Spanish wines.

Your extensive support

- from CRO selection, study design….. to final submission plus your expert insights to EMA procedure details were critical for this success. Very grateful to you!!!

THANK YOU.

B.Z., Director Technical Sales & Support, December 2022

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Strategy, guidance, and dossier assistance

I hope you enjoyed working with us. On my side, it was a great pleasure, you have been with us since the beginning! I well remember the first working session that we had here to discuss the project and the strategy years ago. We then ran the strategy nicely and you were there again to pull together the dossier and guide us during the procedure up to this oral hearing which solved the outstanding issues. We learned a lot there ! Hopefully, we will soon have the opportunity to celebrate our achievements!

L.F., Corporate Performance team leader, Pharma R&D, April, 2022

Scientific Advice for MRL and MUMS

Anja Holm has provided advice and written the request for scientific advice ‘out of scope’ with a positive outcome and acceptance from CVMP. Anja had the competences and was swift in providing the requirements and deliver on time. Further she provided professional advice on timelines and strategy. Anja was an active role in the successful outcome.

- Maibritt Søe, Contura International A/S

Thank you for your guidance

Anja, this achievement is yours as well, congratulations.

Thank you for your guidance on this dossier, and your consideration for the work done by the team.

J.T., Team Leader, Medium-size pharma, April, 2022

Assistance During Pre-Submission of Veterinary Centralised Procedure

Anja is an experienced specialist within her field with a strong dedication and the ability to solve complicated issues. The documentation provided by Anja is of a high scientific and regulatory standard and it goes without saying that she always meets the agreed deadlines. Anja has excellent communication skills and a fine ability for smooth collaboration.

Billev Pharma’s regulatory team requested the assistance of Anja during pre-submission of a veterinary centralised procedure as we did not have the necessary qualifications in-house. We worked together with Anja on the scientific advice with EMA, out-of-scope request and MUMS reclassification of the veterinary medicinal product.

- Ulrikke Lynge Jensen

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Thank you for your guidance through this adventure

Anja,

I just wanted to reiterate again, thank you for your guidance through this adventure. We have made a number of good moves throughout this process and I wanted to personally let you know how much I appreciate working with you on this process and any other potential issues we have going forward.

Your guidance has led us down a very good path on addressing upcoming issues and understanding EU guidance and different organizations throughout European countries.

Again, thank you for all you are doing for us.

- H.H., Senior manager, Oct 2019

The Centralised Procedure for Veterinary Medicinal Products, February 2017

A very comprehensive and interactive training course, which was facilitated greatly with a speaker who provided a valuable insight from the regulators perspective and had good expertise in this area.

- Zahir Ahmed, Vita Europe Ltd.

Referrals for Veterinary Medicinal Products, March 2017

It was a very useful training to differentiate types of referrals and how to manage a referral from a MAH point of view. It was very interesting to have a very experienced speaker answering to all practical questions and to share experiences with others attendees. The dynamic interactive session enable to anticipate how an oral explanation works in reality.

- Frédérique Ducolombier, Merial

CEO of Panion Animal Health AB

Another exciting year for Panion; pleased to be part of the team with Anja E. H. Holm doing a great job!

Annual report 2018 published.

- Lars Friis Mikkelsen, CEO at Ellegaard Göttingen Minipigs

board member at Panion

Panion