We believe in curiosity and developing insights by challenging each other.
Registration & life-cycle mgmt
Strategic Market Access
Managed entry agreements
Access & stakeholder programs
Medinfo & promo materials
Training & effectiveness
Real world evidence
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.
AxTalis Regulatory Affairs provides strategic and technical advice at the highest level throughout the lifecycle of a healthcare solution and helps set the stage for current and future commercial success. Indeed, we see RA not only as a necessity, but as a key partner in the continuous re-evaluation of the scientific and commercial offering, such as indications, SKUs, safety aspects, RMP/RMA etc. The close collaboration with our clients and with the AxTalis Access and Medical Teams allows a targeted intervention to ensure the optimal life cycle management with its obligations and opportunities.
Marketing Authorizations Applications (Centralized, Mutual Recognition, Decentralized or National Procedures)
Product regulatory and legal status
Submission and life cycle management (mod. 1-3)
SmPCs, package insert/instruction for use and labelling (multi-language)
European regulatory strategy and representation
Review and interpretation of regulatory and scientific regulations
Expert report preparation
Non-routine Risk Minimization Activities
Unmet Medical Need & Compassionate Use procedures
Nutrients & biocide notification, submission, and maintenance
MDD 2017/745 and IVD 2017/246, including harmonized standards
Pharmacovigilance support (local contact person and EU QPPV responsibility)
Audit & Inspection readiness (PV, GDP)
QP, RP & RIP
Falsified Medicines Directive requirements and follow-up
AxTalis understands that navigating healthcare systems is complex and not always straightforward as different stakeholders have different needs. By focusing on the key pillars of clinical research, health economics, market research and real-world outcomes research, AxTalis provides stakeholders with the knowledge and insight required to facilitate decision-making. As market access specialists, we work directly with patients, medical specialists, economists and the authorities to find common ground with one goal in mind – access to new technology for patients in need.
Design of Patient and treatment flow
Clinical data analysis
Data gap mitigation plan
Early Access programs
Development of pricing file
Pricing scenario analysis
Indication based pricing
HEOR Budget Impact Analysis
Health Economic Analysis
Strategic RWE (outcome research)
Innovative Managed Entry Agreements
Evidence generating reimbursement
Early dialogue with buyers
KOLs and HCPs
Market Access Ad boards
Parliamentary discussion groups
Patient preference exercises
Axtalis considers Medical Affairs to be a key driver with a critical strategic impact in a healthcare organisation. Medical Affairs helps to define a prioritised strategy that tackles the most important challenges and grasps the most interesting opportunities. Reaching out to the external medical community and engaging with KOL’s, makes Medical Affairs well placed to gather insights and communicate the evidence on how the medical innovation fits the landscape and how it brings value to providers, patients, and payers.
Early Access programs
Real World Evidence & phase IV
Patient Oriented Programs
HCP projects such as speaker kits
Creation of materials
Content for visual aids, brochures
Project evaluation and planning
Review for investment funds