Regulatory management
Clinical trial to post-approval stage
Pharmacovigilance & Medical Information
Compliance & Promo material review
BeNeLux legal roles (RIP, Local QPPV and RP)
Landscape analysis & strategy
Pricing & managed entry agreements
Health economic modelling & reporting
Structured expert elicitation
Value dossier writing
Learning & CME
Scientific & Medical Communication
MSL & Medical Excellence
Real World Data & Evidence
Patient Pathways
Early Access
Our Regulatory Affairs services include healthcare policy and all aspects related to obtaining and maintaining registration of therapeutic solutions. Market Access services include strategic positioning, pricing, and reimbursement, HEOR and managed entry agreements. Services for Medical Affairs include creation and implementation of materials and projects supporting scientific engagement, data generation (RWE) and scientific/market/stakeholder insights. Flexible staffing allows us to provide temporary FTEs to companies on a time or project basis.
Multidisciplinary approach: We don’t look at a specific challenge from one angle, but we take into account a broader set of priorities, and have various functions weigh in on the issues at hand.
Experience: As the AxTalis team has worked in multiple therapeutic areas, we easily understand and navigate in different therapeutic landscapes. We pride ourselves on the ability to quickly come to grasp with new areas and technologies.
Network: Our network spans the broad spectrum of stakeholders and we speak their language.
Expertise: In building experience across a wide range of therapeutic areas, we have developed in-depth knowledge and expertise in Oncology, Haematology, Neurology, Immunology, Pain Management, Cardiology, Diabetes, Nephrology, Ophthalmology, Gastro-enterology, Respiratory, and many others.
We pride ourselves to have a personal relationship with our network of stakeholders, opinion leaders and clients, and we would love to get to know you as well. Feel free to reach out for a chat.
Arthur Vanlaethemstraat 1
9050 Gentbrugge
Belgium
BE0745.587.926
RPR Gent afdeling Gent
Supervising authority for pharmacovigilance: FAMHP
(ADR@fagg.be)
© 2024 Medical Affairs, Market Access and Regulatory Compliance | Privacy Policy | Cookie Policy