Expert services for human medicines – from clinical trials to regulatory affairs and pharmacovigilance
Developing, launching and maintaining a human medicine requires in-depth regulatory knowledge and expertise. Medfiles is a trusted, expert partner to support your clinical trials, regulatory affairs and pharmacovigilance activities. With over 35 years’ experience, we have worked with a wide range of clients – from early stage start-ups to global listed companies.
We offer flexible services based on your needs: single assignments, long-term partnerships or a combination of both.
Regulatory affairs services for human medicines
We support you throughout the entire marketing authorisation process. Our experts can help you develop your regulatory strategy, coordinate submissions and manage post-authorisation maintenance activities.
Our 40-person regulatory team combines in-depth knowledge of local and EU legislation with strong CMC expertise. We handle all EU procedures – decentralised, mutual recognition, national and centralised – and tailor our services to your project. Whether you need help with a single task or full coordination of EU-wide submissions, we’re here to help.
Pharmacovigilance services for human medicines
We provide expert pharmacovigilance support from clinical phase safety profiling through to post-marketing PV systems. Our pharmacovigilance team includes experienced safety experts and safety physicians based in the EU and the US.
Our services include safety profiling, PV system maintenance, adverse event handling, Qualified Person for Pharmacovigilance (QPPV) and medical information services. Support is available as a full service outsourcing solution or for selected tasks tailored to your needs.
Clinical trial services for human medicines
Medfiles is a trusted partner for all phases of clinical trials (I-IV). We support you from early development through to post-marketing studies, providing services from study design to final reporting.
Our services include project coordination, medical writing, regulatory (EU CTIS portal) submissions, study documentation, monitoring, data management and final study reporting. We operate in Finland, the Nordic countries and the Baltic States – and through our extended network we provide services throughout Europe.
Whether your needs are small or large, we’re here to help. Our regulatory affairs, pharmacovigilance and clinical trials teams work closely together to give you access to our extensive expertise in human medicines.
