One of Medfiles’ clients is a global healthcare company specialising in the treatment of serious chronic diseases. Operating across multiple markets, the company manages a broad portfolio of medicinal products requiring continuous regulatory and pharmacovigilance activities at both central and local levels.
The cooperation with Medfiles began in 2021, when the company was looking for a reliable external partner to support its operations.
“Our decision to collaborate with Medfiles was influenced by transparency, communication, a clear cost structureand commercial terms, as well as publicly available reviews of Medfiles,” says a regulatory and pharmacovigilance professional at the company.
Client’s challenge: The client manages a broad portfolio of medicinal products across multiple markets. Overlapping tasks and tight timelines create pressure to maintain quality, reduce errors, and ensure continuity.
Medfiles’ solution: Medfiles provides flexible expert support in regulatory affairs and pharmacovigilance. Support also includes double-checking and back-up resources when needed.
Key benefits: The client is able to manage peak workloads without compromising quality. High volumes of regulatory and pharmacovigilance tasks are handled in parallel, with consistent accuracy and timely delivery. Double-checking reduces the risk of errors, while flexible back-up support ensures that activities continue without delays. This supports ongoing compliance and reliable day-to-day operations.
Flexible support in post-approval regulatory affairs and pharmacovigilance
Since the start of the cooperation, Medfiles has supported the client in a range of regulatory affairs (RA) and pharmacovigilance (PV) tasks.
In regulatory affairs, this has included reviewing and updating product information texts, proofreading regulatory documents, reviewing promotional materials, and placing documentation into internal systems. These activities support lifecycle management across products authorised in the EU.
In pharmacovigilance, Medfiles has contributed to local literature screening and reporting, helping ensure that safety information is identified, assessed, and documented in line with regulatory requirements.
According to the client, one of the key benefits of the cooperation is the ability to manage high workloads and overlapping tasks more effectively. This ensures that critical regulatory and safety activities are completed accurately and on time, even during peak periods or when internal resources are stretched.
“Medfiles provides help and support when we need to perform many tasks at the same time. Their double-checking and quality control reduce the risk of errors. If necessary, they also act as a back-up resource.”
Reliable expertise and responsive collaboration
The client highlights the consistency and reliability of the cooperation with Medfiles’ experts.
“The cooperation has been really good and smooth. The designated Medfiles RA specialist is always available, follows up on communication and performs delegated tasks on time and in accordance with instructions.”
Attention to detail and quality are particularly valued by the client:
“There is high accuracy in working with texts and good quality proofreading. As a support person, the Medfiles expert has also been involved in solving specific regulatory issues.”
The cooperation continues to be an important part of the client’s regulatory and pharmacovigilance operations.
“Thank you for the excellent cooperation, your responsiveness, quality of deliverables and constructive communication. We truly appreciate your support and look forward to continuing our collaboration.”
Medfiles works with pharmaceutical and healthcare companies both applying for marketing authorisation and operating in the post-approval phase. We support companies in both regulatory affairs and pharmacovigilance, from lifecycle management and local submissions to safety monitoring and compliance activities. Solutions are tailored to each client’s needs, from individual projects to full outsourcing.
Global pharma company & Medfiles: Cooperation in obtaining and maintaining marketing authorisations in the EU
“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.”
This is how a client from outside the EU, who has been working with Medfiles for 7 years, describes the partnership. The company initiated cooperation with Medfiles when they required assistance in entering the European market. The cooperation has involved applying for new marketing authorisations as well as managing products post-approval.
