Bimeda is a global innovator and manufacturer of veterinary pharmaceuticals and animal health products. The company was founded in Ireland in 1960 and has since gone on to become a global leader in the animal health industry. Bimeda’s products are sold nowadays in over 80 countries around the world.
Bimeda started to collaborate with Medfiles as soon as they got to know the company.
“I was introduced to Medfiles in CHPI exhibition. After that I had the opportunity to travel to Medfiles’ headquarter in Kuopio to meet their lovely team. From day one, I had a personal feeling that Medfiles was the “must have” partner, so we then started a long and fruitful business relationship that has been running for almost the last 10 years”, says Xavier Molins, Head of Regulatory Affairs from Bimeda.
Xavier has some 30 years of experience in the pharmaceutical industry, mostly in animal health, where he has held different Senior R&D and Regulatory Affairs positions. At present, he’s the Head of Regulatory Affairs in Europe and UK for Bimeda Animal Health Limited. Xavier is also the Chair at Access VetMed, the Association representing the Animal Health generic industry in Europe.
Support in veterinary marketing authorisation applications and maintenance
Medfiles supports Bimeda in various tasks related to veterinary regulatory affairs in the EU. Medfiles enhances Bimeda’s operations through comprehensive assistance in compiling marketing authorisation applications, managing projects, and providing support to address and respond to deficiencies in European decentralised procedures for both generic and auto-generic applications.
In addition, in circumstances of high workload or resources shortage, Medfiles have assisted Bimeda to complete on a timely fashion several maintenance activities, such as key variations and marketing authorisation holder transfers.
According to Xavier, a special advantage of the cooperation has been Medfiles’ CMC competence as well as comprehensive services for all regulatory affairs needs.
“In particular, Medfiles’ very strong CMC expertise has been helpful in performing gap evaluation on existing files, addressing gaps, and preparing updated and upgraded dossiers for submissions in Europe. Medfiles’ diverse team of experts has provided vast knowledge also on national requirements, especially in the Nordic countries, along with additional services like translations for Nordic and Baltic countries.”
Great experiences over the years
Xavier is happy about the past collaboration and also believes in good cooperation in the future.
“Experiences with Medfiles have always been great. Medfiles’ personnel have always been very approachable, respectful, with full availability independently of the season of the year and always happy to help and assist. Thanks to good cooperation and experiences, we have been a satisfied client for many years. Our partnership with Medfiles remains a cornerstone of our success, enabling us to deliver innovative and effective solutions to the animal health market.”
Medfiles offers comprehensive regulatory affairs services for veterinary medicinal products with over 10 years of experience. We are comprised of specialists who are deeply knowledgeable about veterinary legislation and relevant regulatory guidance, including the EU Veterinary Medicinal Products Regulation, national UK legislation, VMD guidance, and US FDA guidance. We’re here to leverage our expertise to help you navigate the registration process smoothly and efficiently.
Free WEBINAR: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
In our webinar you will learn about the main changes and requirements brought about by the Veterinary Medicinal Products Regulation. In the webinar we will discuss variation management and the relationship between pharmacovigilance systems and the related quality measures.
