One of Medfiles’ clients is a global pharmaceutical manufacturing company with a product portfolio that includes analgesics, anti-inflammatory drugs, cardiovascular disease drugs, and antibiotics, among others. The company has a presence around the world, including in many European countries.
The company initiated cooperation with Medfiles when they required assistance in entering the European market.
“Understanding European regulatory regulations can be challenging through internet searches alone. However, thanks to Medfiles’ prompt and accurate consultations, my comprehension of European regulations has significantly improved”, says a representative of the client.
Medfiles helps in marketing authorisation approvals and post-approval product management
The company has been collaborating with Medfiles for about seven years. This cooperation has related to applying for new marketing authorisations as well as managing products post-approval.
“Over the past years, Medfiles has played a crucial role in obtaining approval for our medicinal product in Europe through the DCP process and acted as a Marketing Authorisation applicant during the procedure and as MA holder (MAH) before the launch. Furthermore, whenever we have had regulatory inquiries in Europe, Medfiles has provided appropriate and prompt consultation, not only in the regulatory aspect but also handling responsibilities as a European MAH, such as safety reviews and adverse event reporting”, the client tells.
The client says that when dealing with tasks in European product management, there are often situations where urgent actions are required. Despite seemingly impossible timeframes, Medfiles’ swift cooperation allows the company to progress projects in line with the plans, providing invaluable assistance.
“A while ago when there was an urgent need to release a medicinal product in Italy, despite the tight timeframe, Medfiles played a crucial role in batch release site selection, considering release-related factors, and submitting variation applications. With their assistance, the product was successfully released in Italy within approximately four months, maintaining approval in the country.”
Valuable and reliable support in marketing authorisations in the EU
According to the client, the cooperation has been good, and the company is satisfied with the seven years of working together.
“Medfiles has been a valuable partner for us during the registration and maintenance of products in Europe. They consistently provide prompt and accurate responses whenever there are inquiries or concerns related to European approvals.”
The client appreciates Medfiles’ team of experienced experts in various fields.
“Medfiles experts have been reliable and trustworthy. The expertise and experience of Medfiles’ experts in regulatory affairs, pharmacovigilance, clinical trials, and CMC-related matters make it an advantage to entrust any task to them with confidence.”
“We are satisfied with the services provided by Medfiles. Due to this effective collaboration, we continue to work closely with Medfiles. We look forward to maintaining good collaboration in the future, including upcoming product renewals.”
Medfiles is working with a variety of pharmaceutical companies who are applying for marketing authorisation or who are already in the post-approval phase. Our core competence is in the European market, and we are happy to also assist our non-EU clients aiming for markets in Europe. We offer a one-stop-shop solution for our clients’ outsourcing needs, for businesses of all sizes – from startups to multinational corporations.
Free Guide: WHAT YOU NEED TO KNOW ABOUT ACTIVE SUBSTANCE REGISTRATION STRATEGY?
Drug substance quality must be demonstrated in the marketing authorisation application, and in Europe, there are three different ways to do this. The choice depends mainly on the API in question. The easiest way is to go with CEP whenever possible.
We have created a guide on the basic information you need to know about registration, so that you can make the best choices for your project.
